FDA 510(k)

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

Número K: K260326 · 2026-07-28

Data da decisão2026-07-28

Código do produtoFMZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2026-07-28 under 510(k) number K260326. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2026-07-28. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K260326.

Quando o Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) recebeu a aprovação FDA 510(k)?

Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) received FDA 510(k) clearance on 2026-07-28, under 510(k) number K260326.

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.

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Outros registros que listam Datex-Ohmeda, Inc. como candidato(a)

K254036Novii+ Wireless Patch System K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)K213867Carestation 750/750c K213551Giraffe Omnibed Carestation CS1 K213553O status atual do NCT07471919 (Treinamento de Marcha Assistido por Robô vs. Treinamento de Equilíbrio com Feedback Visual em Acidentes Vasculares Cerebrais) é: RECRUTANDO.K210384CARESCAPE R860

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: FMZ)

K251619Babyleo TN500Drägerwerk AG & Co. KGaA K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators Limited K213553O status atual do NCT07471919 (Treinamento de Marcha Assistido por Robô vs. Treinamento de Equilíbrio com Feedback Visual em Acidentes Vasculares Cerebrais) é: RECRUTANDO.Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

Fonte oficial

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