The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Optomonitor 3.
Device ID | K202943 |
510k Number | K202943 |
Device Name: | OptoMonitor 3 |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | Opsens Inc. 750 Boulevard Du Parc Technologique Quebec, CA G1p 4s3 |
Contact | Marc Chaunet |
Correspondent | Marc Chaunet Opsens Inc. 750 Boulevard Du Parc Technologique Quebec, CA G1p 4s3 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2020-11-24 |
Summary: | summary |