OptoWire Deux
K-Number: K152991 · 2016-02-11
ApplicantOpsens
Decision Date2016-02-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoWire Deux is a medical device manufactured by Opsens. It received FDA 510(k) clearance on 2016-02-11 under approval number K152991. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OptoWire Deux?
OptoWire Deux is a medical device that received FDA 510(k) clearance on 2016-02-11. It is manufactured by Opsens. The 510(k) number is K152991.
When was OptoWire Deux approved by the FDA?
OptoWire Deux received FDA 510(k) clearance on 2016-02-11, under approval number K152991.
What company makes OptoWire Deux?
OptoWire Deux is manufactured by Opsens.
What is the FDA product code for OptoWire Deux?
The FDA product code for OptoWire Deux is DQX.
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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.