FDA 510(k)

HIGH V+

K-Number: K161114 · 2017-04-12

Decision Date2017-04-12

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HIGH V+ is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed Sas. It received FDA 510(k) clearance on 2017-04-12 under 510(k) number K161114. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH V+?

HIGH V+ is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Teknimed Sas. The 510(k) number is K161114.

When did HIGH V+ receive FDA 510(k) clearance?

HIGH V+ received FDA 510(k) clearance on 2017-04-12, under 510(k) number K161114.

Who is the listed applicant for HIGH V+?

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

What is the FDA product code for HIGH V+?

The FDA product code for HIGH V+ is NDN.

Other records listing Teknimed Sas as applicant

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.