Decision Date2018-08-09
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VT - 100, VT - 200 is a medical device manufactured by Carilex Medical, Inc.. It received FDA 510(k) clearance on 2018-08-09 under approval number K173407. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VT - 100, VT - 200?
VT - 100, VT - 200 is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Carilex Medical, Inc.. The 510(k) number is K173407.
When was VT - 100, VT - 200 approved by the FDA?
VT - 100, VT - 200 received FDA 510(k) clearance on 2018-08-09, under approval number K173407.
What company makes VT - 100, VT - 200?
VT - 100, VT - 200 is manufactured by Carilex Medical, Inc..
What is the FDA product code for VT - 100, VT - 200?
The FDA product code for VT - 100, VT - 200 is OMP.
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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.