EVS 3643, EVS 3643G
K-Number: K162552 · 2016-12-02
ApplicantDRTECH Corporation
Decision Date2016-12-02
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EVS 3643, EVS 3643G is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2016-12-02 under approval number K162552. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EVS 3643, EVS 3643G?
EVS 3643, EVS 3643G is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by DRTECH Corporation. The 510(k) number is K162552.
When was EVS 3643, EVS 3643G approved by the FDA?
EVS 3643, EVS 3643G received FDA 510(k) clearance on 2016-12-02, under approval number K162552.
What company makes EVS 3643, EVS 3643G?
EVS 3643, EVS 3643G is manufactured by DRTECH Corporation.
What is the FDA product code for EVS 3643, EVS 3643G?
The FDA product code for EVS 3643, EVS 3643G is MQB.
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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.