K883485 is an FDA 510(k) clearance for the STRYKER PRESSURE MONITOR SYSTEM. This device is classified as a Tape, Measuring, Rulers And Calipers (Class I - General Controls, product code FTY).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 13, 1988, 28 days after receiving the submission on August 16, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K883485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1988 |
| Decision Date | September 13, 1988 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FTY — Tape, Measuring, Rulers And Calipers |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |