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Draegerwerk AG & CO Kgaa

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories5
Latest FDA decision2026-05-07
TypeNumberDevice NameCodeDateActions
510(k) K253647 Evita (V800); Evita (V600)CBK2026-05-07 View
510(k) K242769 VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL2025-04-04 View
510(k) K222822 VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZE2023-06-14 View
510(k) K222024 Evita V800, Evita V600CBK2023-05-16 View
510(k) K222207 Babylog VN800, Babylog VN600CBK2023-05-16 View
510(k) K221118 CO2 Mainstream SensorCCK2023-04-05 View
510(k) K162821 Babyleo TN500FMZ2017-06-23 View
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