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Draeger Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2025-01-17
TypeNumberDevice NameCodeDateActions
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
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