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FDA 510(k)

INFANT RADIANT WARMER

K-Number: K840792 · 1984-05-25

ApplicantHatch Bio Medical
Decision Date1984-05-25
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT RADIANT WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Hatch Bio Medical. It received FDA 510(k) clearance on 1984-05-25 under 510(k) number K840792. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT RADIANT WARMER?

INFANT RADIANT WARMER is a medical device that received FDA 510(k) clearance on 1984-05-25. The listed applicant is Hatch Bio Medical. The 510(k) number is K840792.

When did INFANT RADIANT WARMER receive FDA 510(k) clearance?

INFANT RADIANT WARMER received FDA 510(k) clearance on 1984-05-25, under 510(k) number K840792.

Who is the listed applicant for INFANT RADIANT WARMER?

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

What is the FDA product code for INFANT RADIANT WARMER?

The FDA product code for INFANT RADIANT WARMER is FMT.

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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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