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FDA 510(k)

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

K-Number: K251663 · 2025-10-22

ApplicantDatex-Ohmeda, Inc.
Decision Date2025-10-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is a medical device manufactured by Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2025-10-22 under approval number K251663. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Datex-Ohmeda, Inc.. The 510(k) number is K251663.

When was Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) approved by the FDA?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) received FDA 510(k) clearance on 2025-10-22, under approval number K251663.

What company makes Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is manufactured by Datex-Ohmeda, Inc..

What is the FDA product code for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

The FDA product code for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is FMZ.

Other Devices by Datex-Ohmeda, Inc.

K151570Carestation 620/650/650C K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 K170872Aisys CS2 K172702Tec 820, Tec 850 K210384CARESCAPE R860 K213867Carestation 750/750c

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Related Devices (Code: FMZ)

K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company K162821Babyleo TN500Draegerwerk AG & CO Kgaa K182977Isolette 8000 PlusDraeger Medical Systems, Inc. K172154Isolette 8000 plusDraeger Medical Sytems, Inc. K190494Infant IncubatorNingbo David Medical Device Co., Ltd. K182859Babyleo TN500Dragerwerk AG & CO Kgaa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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