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FDA 510(k)

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing

K-Number: K162159 · 2017-04-28

ApplicantVr Medical Technologies, LLC
Decision Date2017-04-28
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Vr Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162159. 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 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing?

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Vr Medical Technologies, LLC. The 510(k) number is K162159.

When did VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing receive FDA 510(k) clearance?

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162159.

Who is the listed applicant for VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing?

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

What is the FDA product code for VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing?

The FDA product code for VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing is OMP.

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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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