{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-13", "results": { "skip": 0, "limit": 1, "total": 55 } }, "results": [ { "third_party_flag": "N", "city": "Buffalo", "advisory_committee_description": "Cardiovascular", "address_1": "P.O. Box 1274", "address_2": "189 Van Rensselaer St.", "statement_or_summary": "Statement", "product_code": "DRX", "openfda": { "registration_number": [ "", "2031094", "3003584029", "3013522941", "3015058854", "2080225", "3029901632", "2434982", "3011237770", "3011088743", "3008851924", "3003749270", "3030447506", "3014848734", "3016678045", "3007305485", "3006897996", "3014421917", "3010131137", "9681465", "3011307234", "3016761372", "3013681758", "3007770159", "3007184699", "3035642068", "3014220748", "3006227741", "3021219789", "1051786", "1320894", "1000425315", "3009171251", "3031887985", "1718791", "2245574", "3003072803", "3016904853", "3032163717", "2518422", "3020460367", "3004762958", "1063285", "3030446844", "3014982325", "3030626857", "3017567825", "3013557562", "3034669683", "3004040397", "1833310", "1423537", "3010576710", "3001124136", "3011310592", "3014111150", "3006210673", "3013426279", "3008881835", "3043648109", "3004203820", "3018044766", "3014656668", "9680794", "3030733800", "3016096058", "1043214", "3004531359", "3023272766", "3008617703", "1220908", "3016812424", "3010583453", "2025917", "3012027770", "3012606445", "3000126629", "9613910", "1417592", "3008717264", "2133585", "3017425211", "2427500", "3007748793", "3016618143", "3042888450", "3013684844", "3013791928", "3038181770", "3043479346", "1219103", "3016566173", "3000268902", "3009555600", "3011787398", "3014236293", "2320762", "3021632375", "3013298431", "2133409", "3029137407", "9681860", "3004537821", "2438852", "3010363430", "1218950", "3013873578", "8022257", "3031841433", "3006891611", "9612433", "3020977186", "1423662", "1030451", "3008773647", "9710582", "9610816", "3006636961", "3010805941", "3004903538", "3017450375", "3009883402", "3003882387", "1650347", "3010693883", "3022298579", "3038988287", "9613418", "3008114669", "2183164", "3022568093", "3016701404", "3009443693", "3010419931", "3013517171", "3007048259", "3015541720", "3012421607", "3014579161", "3003674698", "1317188", "3011689956", "8043459", "3015286931", "3043226252", "3003074886", "3018783526", "3007734888", "2133542", "9610691", "3005053560", "8020045", "3007699081", "9611295", "3005783425", "3014437893", "3006626283", "3014233600", "3013627970", "3010131466", "3005327291", "3014271754", "3010838917", "3036470679", "3009077524", "3013783488", "3023164", "2022388", "1531159", "3013188547", "3005273623", "3007307487", "3011359729", "1640699", "3012494290", "3008933393", "3003965134", "2025066", "1625392", "3000947648", "1223925", "3010042047", "3011391433", "1221108", "3031233916", "3014982336" ], "fei_number": [ "", "3003584029", "3013522941", "3015058854", "2080225", "3029901632", "2434982", "3003514332", "3011237770", "1000058335", "3011088743", "3002806359", "3008851924", "3003749270", "3030447506", "3014848734", "3016678045", "3007305485", "3006897996", "3014421917", "3010131137", "3003491392", "3011307234", "3016761372", "3013681758", "3007770159", "3007184699", "3002947950", "3035642068", "3014220748", "3006227741", "3001451571", "3021219789", "1051786", "1000425315", "1718791", "3031887985", "3003072803", "3000215273", "2245574", "3006759904", "3016904853", "3032163717", "2518422", "3003757840", "3020460367", "3004762958", "3030446844", "3014982325", "3030626857", "3017567825", "3013557562", "3034669683", "3001236905", "3004040397", "1833310", "1000520174", "3010576710", "3001124136", "1000520785", "3011310592", "3014111150", "3006210673", "3013426279", "3008881835", "3043648109", "3004203820", "3003289183", "3018044766", "3002253377", "3014656668", "3030733800", "1000116809", "3016096058", "1043214", "3004531359", "3023272766", "3008617703", "1220908", "3016812424", "3010583453", "3001236548", "3012027770", "3012606445", "3000126629", "2025917", "1417592", "3008717264", "1000520092", "3017425211", "2427500", "3007748793", "3016618143", "3042888450", "3002807113", "3013684844", "3013791928", "3038181770", "3001044237", "3043479346", "3016566173", "3000268902", "3009555600", "3011787398", "3014236293", "3021632375", "3013298431", "3029137407", "3004537821", "3002807167", "3010363430", "1218950", "3013873578", "3031841433", "3006891611", "1000305720", "3020977186", "1030451", "3008773647", "3006636961", "3010805941", "1000603528", "3004903538", "3017450375", "3004117725", "3009883402", "3003040625", "3003882387", "3003737899", "3010693883", "3022298579", "1000403400", "3038988287", "1000148701", "3008114669", "3022568093", "3016701404", "3009443693", "3010419931", "3013517171", "3007048259", "3015541720", "3012421607", "3014579161", "3002808464", "3003674698", "1317188", "6736", "3011689956", "3043226252", "3015286931", "3003074886", "3018783526", "3007734888", "3005053560", "3007699081", "3005783425", "3014437893", "3006626283", "3002807992", "3014233600", "3013627970", "3010131466", "3005327291", "3014271754", "3010838917", "3036470679", "3009077524", "3013783488", "3023164", "2022388", "3013188547", "3005273623", "3007307487", "3011359729", "3004574120", "1640699", "3012494290", "3008933393", "3003965134", "3000947648", "3010042047", "3011391433", "1221108", "3031233916", "3014982336" ], "device_name": "Electrode, Electrocardiograph", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2360", "device_class": "2" }, "zip_code": "14240", "applicant": "Graphic Controls Corp.", "decision_date": "1995-07-03", "decision_code": "SESE", "country_code": "US", "device_name": "GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE", "advisory_committee": "CV", "contact": "IGNATY GUSAKOV", "expedited_review_flag": "", "k_number": "K950489", "state": "NY", "date_received": "1995-02-06", "review_advisory_committee": "CV", "postal_code": "14240", "decision_description": "Substantially Equivalent", "clearance_type": "Traditional" } ] }