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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K251367
Device Name OptoMonitor 3
Applicant
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA G1P 4S3
Applicant Contact Dany Simard
Correspondent
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA G1P 4S3
Correspondent Contact Dany Simard
Regulation Number870.2870
Classification Product Code
DXO  
Date Received05/01/2025
Decision Date 01/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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