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Draeger Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 45 products

Total Devices45
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260579 Infinity® Acute Care System (IACS) – VG8.1MHX2026-08-20 View
510(k) K243606 Babyroo TN300FMT2025-01-17 View
510(k) K240312 Infinity CentralStation WideMHX2024-08-01 View
510(k) K233834 Infinity Gateway SuiteMSX2024-07-12 View
510(k) K231477 Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX2023-10-17 View
510(k) K230278 Babyroo TN300FMT2023-05-30 View
510(k) K203579 Infinity Gateway SuiteMSX2022-06-07 View
510(k) K203088 Infinity Acute Care System (IACS) Monitoring SystemMHX2022-02-01 View
510(k) K201764 Infinity Acute Care System (IACS) Monitoring SolutionMHX2021-12-09 View
510(k) K200859 Infinity M300MHX2020-08-28 View
510(k) K182977 Isolette 8000 PlusFMZ2018-11-21 View
510(k) K172656 BiliLuxLBI2018-05-01 View
510(k) K130711 INFINITY CENTRALSTATION WITH INFINITY M300MHX2013-04-11 View
510(k) K120642 RESUSCITAIRE WITH AUTOBREATHFMT2012-11-02 View
510(k) K113798 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETMHX2012-03-22 View
510(k) K113206 NANOBLUTM 500LBI2012-02-17 View
510(k) K103625 OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICECBK2011-10-06 View
510(k) K102968 INFINITY CNAP SMARTPODDXN2011-02-18 View
510(k) K093788 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONMHX2010-03-08 View
510(k) K082888 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997DQA2008-11-26 View
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