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General Devices

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K013533 EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)DRG2002-01-18 View
510(k) K002089 ROSETTA-LT/ROSETTA-RXDRG2000-11-21 View
510(k) K993202 EIM-107 PREP-CHECKGZO1999-12-17 View
510(k) K940009 GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300DRG1995-04-14 View
510(k) K935839 GEMSCOM SERIES 5000,DRG1994-11-10 View
510(k) K921929 GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)DXH1992-09-18 View
510(k) K914889 GEMSCOM SERIES 3000DRG1992-03-04 View
510(k) K912008 TRU-VIEW MULTI-CHANNEL DISPLAYDRT1991-10-09 View
510(k) K896153 MODIFIED DR-2C/PMC 100DSH1990-01-19 View
510(k) K862596 DR-2C (MODIFICATION)DSF1986-09-26 View
510(k) K844650 DR-2CDXJ1985-01-22 View
510(k) K830877 AP-CHECKGYA1983-06-08 View
510(k) K830876 PREP-CHECKKRC1983-05-18 View
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