K844214 is an FDA 510(k) clearance for the COMPARTMENT SYNDROME PRESSURE MONITOR SYS. This device is classified as a Monitor, Pressure, Intracompartmental.
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on April 4, 1985, 155 days after receiving the submission on October 31, 1984.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K844214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1984 |
| Decision Date | April 04, 1985 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LXC — Monitor, Pressure, Intracompartmental |
| Device Class | — |