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FDA 510(k)

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)

K-Number: K970074 · 1997-04-03

ApplicantHill-Rom, Inc.
Decision Date1997-04-03
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom, Inc.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K970074. 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 STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)?

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Hill-Rom, Inc.. The 510(k) number is K970074.

When did STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) receive FDA 510(k) clearance?

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) received FDA 510(k) clearance on 1997-04-03, under 510(k) number K970074.

Who is the listed applicant for STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)?

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

What is the FDA product code for STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)?

The FDA product code for STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) 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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