FDA 510(k)

Giraffe OmniBed Carestation CS1

Número K: K152814 · 2016-03-17

RequerenteOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company

Data da decisão2016-03-17

Código do produtoFMZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Giraffe OmniBed Carestation CS1 is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152814. 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 OmniBed Carestation CS1 is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. The 510(k) number is K152814.

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

Giraffe OmniBed Carestation CS1 received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152814.

Who is the listed applicant for Giraffe OmniBed Carestation CS1?

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

What is the FDA product code for Giraffe OmniBed Carestation CS1?

The FDA product code for Giraffe OmniBed Carestation CS1 is FMZ.

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Dispositivos Relacionados (Código: FMZ)

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.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.

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