K912237 is an FDA 510(k) clearance for the STRYKER ECLIPSE WARMING STRETCHER. This device is classified as a Saw, Electrically Powered (Class I - General Controls, product code DWI).
Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on July 30, 1991, 70 days after receiving the submission on May 21, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K912237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1991 |
| Decision Date | July 30, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | DWI — Saw, Electrically Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |