K202635 is an FDA 510(k) clearance for the MY01 Continuous Compartmental Pressure Monitor. This device is classified as a Monitor, Pressure, Intracompartmental.
Submitted by MY01, Inc. (Montreal, CA). The FDA issued a Cleared decision on December 10, 2020, 90 days after receiving the submission on September 11, 2020.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K202635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2020 |
| Decision Date | December 10, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXC - Monitor, Pressure, Intracompartmental |
| Device Class | - |