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FDA 510(k)

INFANT WARMER

K-Number: K833802 · 1984-04-05

ApplicantKinetic Concepts, Inc.
Decision Date1984-04-05
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K833802. 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 WARMER?

INFANT WARMER is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K833802.

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

INFANT WARMER received FDA 510(k) clearance on 1984-04-05, under 510(k) number K833802.

Who is the listed applicant for INFANT WARMER?

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

What is the FDA product code for INFANT WARMER?

The FDA product code for INFANT 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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