VARIOunite
K-Number: K160244 · 2016-06-02
ApplicantThommen Medical AG
Decision Date2016-06-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
VARIOunite is a medical device manufactured by Thommen Medical AG. It received FDA 510(k) clearance on 2016-06-02 under approval number K160244. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VARIOunite?
VARIOunite is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Thommen Medical AG. The 510(k) number is K160244.
When was VARIOunite approved by the FDA?
VARIOunite received FDA 510(k) clearance on 2016-06-02, under approval number K160244.
What company makes VARIOunite?
VARIOunite is manufactured by Thommen Medical AG.
What is the FDA product code for VARIOunite?
The FDA product code for VARIOunite is NHA.
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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.