The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Compartment Syndrome Pressure Monitor Sys.
| Device ID | K844214 |
| 510k Number | K844214 |
| Device Name: | COMPARTMENT SYNDROME PRESSURE MONITOR SYS |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Mary C Mastenbrook |
| Correspondent | Mary C Mastenbrook STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-31 |
| Decision Date | 1985-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007350048 | K844214 | 000 |
| 00850007350031 | K844214 | 000 |
| 00850007350024 | K844214 | 000 |
| 00850007350017 | K844214 | 000 |
| 00850007350000 | K844214 | 000 |
| 00850007350055 | K844214 | 000 |
| 00850007350192 | K844214 | 000 |
| 00850007350185 | K844214 | 000 |