HIGH V+
K-Number: K161114 · 2017-04-12
ApplicantTeknimed Sas
Decision Date2017-04-12
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
HIGH V+ is a medical device manufactured by Teknimed Sas. It received FDA 510(k) clearance on 2017-04-12 under approval 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. It is manufactured by Teknimed Sas. The 510(k) number is K161114.
When was HIGH V+ approved by the FDA?
HIGH V+ received FDA 510(k) clearance on 2017-04-12, under approval number K161114.
What company makes HIGH V+?
HIGH V+ is manufactured by Teknimed Sas.
What is the FDA product code for HIGH V+?
The FDA product code for HIGH V+ is NDN.
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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.