OptoMonitor
K-Number: K192340 · 2019-12-12
ApplicantOpsens, Inc.
Decision Date2019-12-12
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoMonitor is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2019-12-12 under approval number K192340. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OptoMonitor?
OptoMonitor is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Opsens, Inc.. The 510(k) number is K192340.
When was OptoMonitor approved by the FDA?
OptoMonitor received FDA 510(k) clearance on 2019-12-12, under approval number K192340.
What company makes OptoMonitor?
OptoMonitor is manufactured by Opsens, Inc..
What is the FDA product code for OptoMonitor?
The FDA product code for OptoMonitor is DXO.
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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.