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FDA 510(k)

MP4, MP4SI, IT4 INCUBATORS

K-Number: K901157 · 1991-03-27

ApplicantMediprema
Decision Date1991-03-27
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MP4, MP4SI, IT4 INCUBATORS is the device name listed in this FDA 510(k) record. The listed applicant is Mediprema. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K901157. 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 MP4, MP4SI, IT4 INCUBATORS?

MP4, MP4SI, IT4 INCUBATORS is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Mediprema. The 510(k) number is K901157.

When did MP4, MP4SI, IT4 INCUBATORS receive FDA 510(k) clearance?

MP4, MP4SI, IT4 INCUBATORS received FDA 510(k) clearance on 1991-03-27, under 510(k) number K901157.

Who is the listed applicant for MP4, MP4SI, IT4 INCUBATORS?

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

What is the FDA product code for MP4, MP4SI, IT4 INCUBATORS?

The FDA product code for MP4, MP4SI, IT4 INCUBATORS is FMZ.

Related Clinical Trials

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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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