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FDA 510(k)

VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM

K-Number: K041473 · 2004-07-15

ApplicantVortran Medical Technology 1, Inc.
Decision Date2004-07-15
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2004-07-15 under 510(k) number K041473. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM?

VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM is a medical device that received FDA 510(k) clearance on 2004-07-15. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K041473.

When did VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM receive FDA 510(k) clearance?

VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM received FDA 510(k) clearance on 2004-07-15, under 510(k) number K041473.

Who is the listed applicant for VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM?

The FDA product code for VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM is BTL.

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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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