K962181 is an FDA 510(k) clearance for the HARE MODEL 2000 EZ LOADER MODEL 95555. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on August 1, 1996, 56 days after receiving the submission on June 6, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K962181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1996 |
| Decision Date | August 01, 1996 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPO — Stretcher, Wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6910 |