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Eigen

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K222222 Artemis, Artemis TPO, Artemis MXQTZ2023-10-12 View
510(k) K173744 ProFuse CADLLZ2018-11-21 View
510(k) K162474 ArtemisLLZ2016-10-21 View
510(k) K063846 EIGEN DSA 2000LLZ2007-01-26 View
510(k) K933115 DIGITAL DISK RECORDERLMB1994-04-07 View
510(k) K924164 DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPTJAA1992-11-23 View
510(k) K923585 DIGITAL FLUORO STOREJAA1992-10-21 View
510(k) K913012 DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXESJAA1991-09-23 View
510(k) K905111 DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXESJAA1991-01-25 View
510(k) K903821 PSC-1 W/OTHER NUMERICALJAA1990-11-07 View
510(k) K902927 DIGITAL PHOTOSPOTJAA1990-08-03 View
510(k) K901956 DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)LMB1990-07-02 View
510(k) K890745 SC-1000 WITH SUFFIXES (SCAN CONVERTER)JAA1989-03-14 View
510(k) K882175 HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVPJAA1988-08-19 View
510(k) K882176 VTR-12JAA1988-08-11 View
510(k) K882184 HR-1000 W/SUFFIXES (B,C OR D)LMB1988-06-28 View
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