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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 the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) 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. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K251663.

When did Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

The FDA 510(k) record lists Datex-Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Datex-Ohmeda, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254036Novii+ Wireless Patch SystemK260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)K231964Novii+ Wireless Patch SystemK213867Carestation 750/750cK213553Giraffe Incubator Carestation CS1K213551Giraffe Omnibed Carestation CS1

View all 12 devices →

Related Devices (Code: FMZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, 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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