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FDA 510(k)

Giraffe OmniBed Carestation CS1

K-Number: K152814 · 2016-03-17

ApplicantOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
Decision Date2016-03-17
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

Official Source

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

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