OptoMonitor 3

Transducer, Pressure, Catheter Tip

Opsens Inc.

The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Optomonitor 3.

Pre-market Notification Details

Device IDK193620
510k NumberK193620
Device Name:OptoMonitor 3
ClassificationTransducer, Pressure, Catheter Tip
Applicant Opsens Inc. 750 Boulevard Du Parc Technologique Quebec,  CA G1p 4s3
ContactMarc Chaunet
CorrespondentMarc Chaunet
Opsens Inc. 750 Boulevard Du Parc Technologique Quebec,  CA G1p 4s3
Product CodeDXO  
CFR Regulation Number870.2870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-06-18

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