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FDA 510(k)

VITALHEAT

K-Number: K040911 · 2004-06-22

ApplicantDynatherm Medical, Inc.
Decision Date2004-06-22
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALHEAT is the device name listed in this FDA 510(k) record. The listed applicant is Dynatherm Medical, Inc.. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K040911. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALHEAT?

VITALHEAT is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is Dynatherm Medical, Inc.. The 510(k) number is K040911.

When did VITALHEAT receive FDA 510(k) clearance?

VITALHEAT received FDA 510(k) clearance on 2004-06-22, under 510(k) number K040911.

Who is the listed applicant for VITALHEAT?

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

What is the FDA product code for VITALHEAT?

The FDA product code for VITALHEAT is DWJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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