K161263 is an FDA 510(k) clearance for the OptoMonitor II. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on September 13, 2016, 131 days after receiving the submission on May 5, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K161263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2016 |
| Decision Date | September 13, 2016 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXO - Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |