FDA 510(k)

Giraffe Incubator Carestation CS1

K-Number: K213553 · 2022-03-02

Decision Date2022-03-02

Product CodeFMZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Giraffe Incubator Carestation CS1 is a medical device manufactured by Datex Ohmeda, Inc.. It received FDA 510(k) clearance on 2022-03-02 under approval number K213553. 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 Incubator Carestation CS1?

Giraffe Incubator Carestation CS1 is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Datex Ohmeda, Inc.. The 510(k) number is K213553.

When was Giraffe Incubator Carestation CS1 approved by the FDA?

Giraffe Incubator Carestation CS1 received FDA 510(k) clearance on 2022-03-02, under approval number K213553.

What company makes Giraffe Incubator Carestation CS1?

Giraffe Incubator Carestation CS1 is manufactured by Datex Ohmeda, Inc..

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

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

Other Devices by Datex Ohmeda, Inc.

K213551Giraffe Omnibed Carestation CS1

Related Devices (Code: FMZ)

K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company K162821Babyleo TN500Draegerwerk AG & CO Kgaa K182977Isolette 8000 PlusDraeger Medical Systems, Inc. K172154Isolette 8000 plusDraeger Medical Sytems, Inc. K190494Infant IncubatorNingbo David Medical Device Co., Ltd. K182859Babyleo TN500Dragerwerk AG & CO Kgaa

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.