OptoMonitor
Transducer, Pressure, Catheter Tip
Opsens Inc
The following data is part of a premarket notification filed by Opsens Inc with the FDA for Optomonitor.
Pre-market Notification Details
| Device ID | K192340 |
| 510k Number | K192340 |
| Device Name: | OptoMonitor |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Opsens Inc 750 Boulevard Du Parc Technologique Quebec, CA Gip 4s3 |
| Contact | Marc Chaunet |
| Correspondent | Chris Henza Ultra LifeScience Inc. 872 S. Milwaukee Avenue #286 Libertyville, IL 60048 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-28 |
| Decision Date | 2019-12-12 |
Trademark Results [OptoMonitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTOMONITOR 86384225 5069180 Live/Registered |
OPSENS INC. 2014-09-03 |
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