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Compumedics Limited

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252383 Somfit DMNR2025-08-28 View
510(k) K242447 Falcon HSTOLV2025-02-20 View
510(k) K231546 SomfitMNR2023-11-30 View
510(k) K230073 OktiGWQ2023-02-09 View
510(k) K191785 Orion LifeSpan MEGOLY2020-02-14 View
510(k) K093223 COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECGGWQ2010-01-15 View
510(k) K072201 COMPUMEDICS SOMTE PSG RECORDING SYSTEMMNR2008-04-14 View
510(k) K021176 COMPUMEDICS SOMTE SYSTEMMNR2003-01-21 View
510(k) K003175 COMPUMEDICS SIESTA SYSTEMOLV2000-12-27 View
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