ClearanceBrief
510(k) K101788 ยท FMZ Incubator, Neonatal

GIRAFFE OMNIBED

ApplicantOhmeda Medical, Laurel MD, US
DecisionSubstantially Equivalent, Jul 21, 2010
ReceivedJun 25, 2010
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K101788

DateFirm and productCodeLinked 510(k)
Jun 17, 2026GE Medical Systems, LLC
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Open, Classified		 FMZNone listed
Jun 17, 2026GE Medical Systems, LLC
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Open, Classified		 FMZNone listed
Oct 17, 2024DATEX--OHMEDA, INC.
GE Heathcare Giraffe OmniBed; neo natal incubator
Open, Classified		 FMZNone listed
Jul 6, 2023DATEX--OHMEDA, INC.
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901
Open, Classified		 FMZNone listed
May 22, 2020GE Healthcare, LLC
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Terminated		 FMZNone listed
Apr 28, 2020GE Healthcare, LLC
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Terminated		 FMZNone listed
Dec 3, 2019GE Healthcare, LLC
Giraffe OmniBed infant warmer
Terminated		 FMTNone listed
Apr 5, 2013GE Healthcare, LLC
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnib
Terminated		 FMZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.