The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Pressure Monitor System.
| Device ID | K883485 |
| 510k Number | K883485 |
| Device Name: | STRYKER PRESSURE MONITOR SYSTEM |
| Classification | Expander, Skin, Inflatable |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Harmon H Woodworth |
| Correspondent | Harmon H Woodworth STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-09-13 |