OptoWire III
K-Number: K191907 · 2020-01-02
ApplicantOpsens, Inc.
Decision Date2020-01-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoWire III is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2020-01-02 under approval number K191907. 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 III?
OptoWire III is a medical device that received FDA 510(k) clearance on 2020-01-02. It is manufactured by Opsens, Inc.. The 510(k) number is K191907.
When was OptoWire III approved by the FDA?
OptoWire III received FDA 510(k) clearance on 2020-01-02, under approval number K191907.
What company makes OptoWire III?
OptoWire III is manufactured by Opsens, Inc..
What is the FDA product code for OptoWire III?
The FDA product code for OptoWire III 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.