K192340 is an FDA 510(k) clearance for the OptoMonitor. 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 December 12, 2019, 106 days after receiving the submission on August 28, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K192340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2019 |
| Decision Date | December 12, 2019 |
| Days to Decision | 106 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 |