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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 K192340
Device Name OptoMonitor
Applicant
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA GIP 4S3
Applicant Contact Marc Chaunet
Correspondent
Ultra Lifescience, Inc.
872 S. Milwaukee Ave. #286
Libertyville,  IL  60048
Correspondent Contact Chris Henza
Regulation Number870.2870
Classification Product Code
DXO  
Date Received08/28/2019
Decision Date 12/12/2019
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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