FDA 510(k)

C-300 INFANT INCUBATOR

K-Number: K821896 · 1982-07-28

Decision Date1982-07-28

Product CodeFMZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

C-300 INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Narco Scientific. It received FDA 510(k) clearance on 1982-07-28 under 510(k) number K821896. 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 C-300 INFANT INCUBATOR?

C-300 INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 1982-07-28. The listed applicant is Narco Scientific. The 510(k) number is K821896.

When did C-300 INFANT INCUBATOR receive FDA 510(k) clearance?

C-300 INFANT INCUBATOR received FDA 510(k) clearance on 1982-07-28, under 510(k) number K821896.

Who is the listed applicant for C-300 INFANT INCUBATOR?

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

What is the FDA product code for C-300 INFANT INCUBATOR?

The FDA product code for C-300 INFANT INCUBATOR is FMZ.

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Related Devices (Code: FMZ)

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaA K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators Limited K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

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.