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FDA 510(k)

INCUBATOR 8000 SC

K-Number: K914134 · 1991-11-22

ApplicantNational Draeger, Inc.
Decision Date1991-11-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INCUBATOR 8000 SC is the device name listed in this FDA 510(k) record. The listed applicant is National Draeger, Inc.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914134. 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 INCUBATOR 8000 SC?

INCUBATOR 8000 SC is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is National Draeger, Inc.. The 510(k) number is K914134.

When did INCUBATOR 8000 SC receive FDA 510(k) clearance?

INCUBATOR 8000 SC received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914134.

Who is the listed applicant for INCUBATOR 8000 SC?

The FDA 510(k) record lists National Draeger, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCUBATOR 8000 SC?

The FDA product code for INCUBATOR 8000 SC is FMZ.

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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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