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FDA 510(k)

ISOLETTE INCUBATOR C-100

K-Number: K802126 · 1980-09-26

ApplicantNarco Air-Shields
Decision Date1980-09-26
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLETTE INCUBATOR C-100 is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802126. 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 ISOLETTE INCUBATOR C-100?

ISOLETTE INCUBATOR C-100 is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Narco Air-Shields. The 510(k) number is K802126.

When did ISOLETTE INCUBATOR C-100 receive FDA 510(k) clearance?

ISOLETTE INCUBATOR C-100 received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802126.

Who is the listed applicant for ISOLETTE INCUBATOR C-100?

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

What is the FDA product code for ISOLETTE INCUBATOR C-100?

The FDA product code for ISOLETTE INCUBATOR C-100 is FMZ.

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Other records listing Narco Air-Shields as applicant

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K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.K810953MODEL 533 PHOTOTHERAPY UNITK810474PROBE COVERK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK792592AMBU UNIVERSAL SUCTION PUMPK792499AMBU PAEDI ANAESTHESIA SYSTEM

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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

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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