FDA 510(k)

ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT

K-Number: K120033 · 2012-05-31

Decision Date2012-05-31

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2012-05-31 under 510(k) number K120033. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT?

ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT is a medical device that received FDA 510(k) clearance on 2012-05-31. The listed applicant is Kci USA, Inc.. The 510(k) number is K120033.

When did ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT receive FDA 510(k) clearance?

ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT received FDA 510(k) clearance on 2012-05-31, under 510(k) number K120033.

Who is the listed applicant for ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT?

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

What is the FDA product code for ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT?

The FDA product code for ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT is OMP.

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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.