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 a medical device manufactured by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. It received FDA 510(k) clearance on 2016-03-17 under approval 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. It is manufactured by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. The 510(k) number is K152814.

When was Giraffe OmniBed Carestation CS1 approved by the FDA?

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

What company makes Giraffe OmniBed Carestation CS1?

Giraffe OmniBed Carestation CS1 is manufactured by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company.

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)

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 K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.

Official Source

View on FDA Database →

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