OptoMonitor 3
K-Number: K241418 · 2025-02-12
ApplicantOpsens, Inc.
Decision Date2025-02-12
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoMonitor 3 is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2025-02-12 under approval number K241418. 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 3?
OptoMonitor 3 is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Opsens, Inc.. The 510(k) number is K241418.
When was OptoMonitor 3 approved by the FDA?
OptoMonitor 3 received FDA 510(k) clearance on 2025-02-12, under approval number K241418.
What company makes OptoMonitor 3?
OptoMonitor 3 is manufactured by Opsens, Inc..
What is the FDA product code for OptoMonitor 3?
The FDA product code for OptoMonitor 3 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.