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FDA 510(k)

Giraffe Incubator Carestation CS1

K-Number: K213553 · 2022-03-02

ApplicantDatex Ohmeda, Inc.
Decision Date2022-03-02
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Giraffe Incubator 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 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. The listed applicant is Datex Ohmeda, Inc.. The 510(k) number is K213553.

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

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

Who is the listed applicant for Giraffe Incubator 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 Incubator Carestation CS1?

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

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 750/750cK213551Giraffe Omnibed Carestation CS1

View all 12 devices →

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 LimitedK190494Infant IncubatorNingbo David Medical Device Co., Ltd.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

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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