K050753 is an FDA 510(k) clearance for the STRYKER DISCMONITOR. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 18, 2005, 56 days after receiving the submission on March 23, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K050753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2005 |
| Decision Date | May 18, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |