FDA 510(k)

NewTom VGi evo

K-Number: K151612 · 2016-03-31

Decision Date2016-03-31

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NewTom VGi evo is the device name listed in this FDA 510(k) record. The listed applicant is Qr S.R.L.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K151612. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NewTom VGi evo?

NewTom VGi evo is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Qr S.R.L.. The 510(k) number is K151612.

When did NewTom VGi evo receive FDA 510(k) clearance?

NewTom VGi evo received FDA 510(k) clearance on 2016-03-31, under 510(k) number K151612.

Who is the listed applicant for NewTom VGi evo?

The FDA 510(k) record lists Qr S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NewTom VGi evo?

The FDA product code for NewTom VGi evo is OAS.

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.