The following data is part of a premarket notification filed by Opsens Inc with the FDA for Optomonitor Ii.
| Device ID | K161263 |
| 510k Number | K161263 |
| Device Name: | OptoMonitor II |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Opsens Inc 750, Boulevard Du Parc Technologique Quebec, CA Gip 4s3 |
| Contact | Vanessa Mootoosamy |
| Correspondent | Chris Henza Ultra LifeScience Solutions Inc 146 N. Greenview Ave Mundelein, IL 60060 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2016-09-13 |
| Summary: | summary |