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Datex Ohmeda, Inc.

FDA 510(k) & PMA Approved Devices — 59 products

Total Devices59
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K254036 Novii+ Wireless Patch SystemHGM2026-08-10 View
510(k) K260326 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZ2026-07-28 View
510(k) K251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ2025-10-22 View
510(k) K213867 Carestation 750/750cBSZ2023-03-28 View
510(k) K213553 Giraffe Incubator Carestation CS1FMZ2022-03-02 View
510(k) K213551 Giraffe Omnibed Carestation CS1FMT2022-03-02 View
510(k) K210384 CARESCAPE R860CBK2021-11-04 View
510(k) K172702 Tec 820, Tec 850CAD2018-01-04 View
510(k) K172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2BSZ2017-11-03 View
510(k) K170872 Aisys CS2BSZ2017-08-15 View
510(k) K151570 Carestation 620/650/650CBSZ2016-01-21 View
510(k) K132530 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)BSZ2013-12-20 View
510(k) K123125 GE DATEX-OHMEDA AVANCE CS2BSZ2013-02-06 View
510(k) K112722 GE DATEX-OHMEDA AVANCEBSZ2011-12-16 View
510(k) K110213 GE DATEX-OHMEDA AISYSBSZ2011-07-20 View
510(k) K090233 GE DATEX-OHMEDA AISYSBSZ2009-03-05 View
510(k) K081842 ENGSTROM CARESTATION, ENGSTROM PROCBK2008-10-03 View
510(k) K081844 GE DATEX-OHMEDA AVANCEBSZ2008-08-29 View
510(k) K073707 GE DATEX-OHMEDA AISYSBSZ2008-01-30 View
510(k) K072512 MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMZ2007-10-03 View
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