FDA 510(k)

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

K-번호: K251663 · 2025-10-22

결정일2025-10-22

제품 코드FMZ

자문 위원회HO

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Datex-Ohmeda, Inc.를 신청인으로 등재한 기타 기록

K254036Novii+ Wireless Patch System K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)K213867Carestation 750/750c K213551Giraffe Omnibed Carestation CS1 K213553Giraffe Incubator Carestation CS1 K210384CARESCAPE R860

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