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Draeger Medical Systems, Inc.

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

Total Devices11
Categories5
Latest Approval2025-01-17
TypeNumberDevice NameCodeDate
510(k) K243606 Babyroo TN300 FMT 2025-01-17 View
510(k) K240312 Infinity CentralStation Wide MHX 2024-08-01 View
510(k) K233834 Infinity Gateway Suite MSX 2024-07-12 View
510(k) K231477 Infinity CentralStation Wide, Infinity M300, Infinity M300+ MHX 2023-10-17 View
510(k) K230278 Babyroo TN300 FMT 2023-05-30 View
510(k) K203579 Infinity Gateway Suite MSX 2022-06-07 View
510(k) K203088 Infinity Acute Care System (IACS) Monitoring System MHX 2022-02-01 View
510(k) K201764 Infinity Acute Care System (IACS) Monitoring Solution MHX 2021-12-09 View
510(k) K200859 Infinity M300 MHX 2020-08-28 View
510(k) K182977 Isolette 8000 Plus FMZ 2018-11-21 View
510(k) K172656 BiliLux LBI 2018-05-01 View
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