FDA 510(k)

V-DENUPET

K-Number: K192146 · 2020-01-28

Decision Date2020-01-28

Product CodeMQH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

V-DENUPET is the device name listed in this FDA 510(k) record. The listed applicant is Vitromed GmbH. It received FDA 510(k) clearance on 2020-01-28 under 510(k) number K192146. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-DENUPET?

V-DENUPET is a medical device that received FDA 510(k) clearance on 2020-01-28. The listed applicant is Vitromed GmbH. The 510(k) number is K192146.

When did V-DENUPET receive FDA 510(k) clearance?

V-DENUPET received FDA 510(k) clearance on 2020-01-28, under 510(k) number K192146.

Who is the listed applicant for V-DENUPET?

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

What is the FDA product code for V-DENUPET?

The FDA product code for V-DENUPET is MQH.

Other records listing Vitromed GmbH as applicant

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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.