OptoMonitor II
K-Number: K161263 · 2016-09-13
ApplicantOpsens, Inc.
Decision Date2016-09-13
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoMonitor II is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2016-09-13 under approval number K161263. 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 II?
OptoMonitor II is a medical device that received FDA 510(k) clearance on 2016-09-13. It is manufactured by Opsens, Inc.. The 510(k) number is K161263.
When was OptoMonitor II approved by the FDA?
OptoMonitor II received FDA 510(k) clearance on 2016-09-13, under approval number K161263.
What company makes OptoMonitor II?
OptoMonitor II is manufactured by Opsens, Inc..
What is the FDA product code for OptoMonitor II?
The FDA product code for OptoMonitor II 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.