K223509 is an FDA 510(k) clearance for the Compremium Compartment Compressibility Monitoring System (CPM#1). This device is classified as a Monitor, Pressure, Intracompartmental.
Submitted by Compremium AG (Muri, CH). The FDA issued a Cleared decision on April 14, 2023, 143 days after receiving the submission on November 22, 2022.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K223509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2022 |
| Decision Date | April 14, 2023 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXC - Monitor, Pressure, Intracompartmental |
| Device Class | - |