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FDA 510(k)

Giraffe Omnibed Carestation CS1

K-Number: K213551 · 2022-03-02

ApplicantDatex Ohmeda, Inc.
Decision Date2022-03-02
Product CodeFMT
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 Datex Ohmeda, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213551. The device is classified under product code FMT. 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 2022-03-02. The listed applicant is Datex Ohmeda, Inc.. The 510(k) number is K213551.

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

Giraffe Omnibed Carestation CS1 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213551.

Who is the listed applicant for Giraffe Omnibed 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?

The FDA product code for Giraffe Omnibed Carestation CS1 is FMT.

Other records listing Datex Ohmeda, Inc. as applicant

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.

K254036Novii+ Wireless Patch SystemK260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)K231964Novii+ Wireless Patch SystemK213867Carestation 750/750cK213553Giraffe Incubator Carestation CS1

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Related Devices (Code: FMT)

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.

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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.

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