K946101 is an FDA 510(k) clearance for the EMERGENCY/ACCIDENT TROLLEY 550. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on February 7, 1995, 55 days after receiving the submission on December 14, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K946101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPO — Stretcher, Wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6910 |