Submission Details
| 510(k) Number | K942356 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 1994 |
| Decision Date | July 19, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K942356 is an FDA 510(k) clearance for the MED-EVAC-4 MEDICAL EVACUATION STRETCHER, a Stretcher, Hand-carried (Class I — General Controls, product code FPP), submitted by Montery Bay Corp. (Columbia, US). The FDA issued a Cleared decision on July 19, 1994, 63 days after receiving the submission on May 17, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6900.
| 510(k) Number | K942356 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 1994 |
| Decision Date | July 19, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPP — Stretcher, Hand-carried |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6900 |