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FDA 510(k)

BABYTHERM 8004 BABYTHERM 8010

K-Number: K971198 · 1997-10-03

ApplicantDrager, Inc.
Decision Date1997-10-03
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BABYTHERM 8004 BABYTHERM 8010 is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K971198. 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 BABYTHERM 8004 BABYTHERM 8010?

BABYTHERM 8004 BABYTHERM 8010 is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Drager, Inc.. The 510(k) number is K971198.

When did BABYTHERM 8004 BABYTHERM 8010 receive FDA 510(k) clearance?

BABYTHERM 8004 BABYTHERM 8010 received FDA 510(k) clearance on 1997-10-03, under 510(k) number K971198.

Who is the listed applicant for BABYTHERM 8004 BABYTHERM 8010?

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

What is the FDA product code for BABYTHERM 8004 BABYTHERM 8010?

The FDA product code for BABYTHERM 8004 BABYTHERM 8010 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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