The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Optomonitor 3.
| Device ID | K193620 |
| 510k Number | K193620 |
| 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 | 2019-12-26 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540184132010 | K193620 | 000 |
| 07540184320103 | K193620 | 000 |
| 07540184320110 | K193620 | 000 |
| 07540184320127 | K193620 | 000 |
| 07540184020096 | K193620 | 000 |
| 07540184020119 | K193620 | 000 |
| 07540184020126 | K193620 | 000 |
| 07540184023103 | K193620 | 000 |
| 07540184023202 | K193620 | 000 |
| 07540184023219 | K193620 | 000 |
| 07540184023301 | K193620 | 000 |
| 07540184320097 | K193620 | 000 |