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FDA 510(k)

BIRTHING ROOM WARMER

K-Number: K871594 · 1987-06-05

ApplicantAir-Shields, Inc.
Decision Date1987-06-05
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIRTHING ROOM WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1987-06-05 under 510(k) number K871594. 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 BIRTHING ROOM WARMER?

BIRTHING ROOM WARMER is a medical device that received FDA 510(k) clearance on 1987-06-05. The listed applicant is Air-Shields, Inc.. The 510(k) number is K871594.

When did BIRTHING ROOM WARMER receive FDA 510(k) clearance?

BIRTHING ROOM WARMER received FDA 510(k) clearance on 1987-06-05, under 510(k) number K871594.

Who is the listed applicant for BIRTHING ROOM WARMER?

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

What is the FDA product code for BIRTHING ROOM WARMER?

The FDA product code for BIRTHING ROOM 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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