K112502 is an FDA 510(k) clearance for the PROCEDURAL STRECHER WITH INTELLIDRIVE P8000. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).
Submitted by Hill-Rom Co. (Batesville, US). The FDA issued a Cleared decision on September 19, 2011, 20 days after receiving the submission on August 30, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K112502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2011 |
| Decision Date | September 19, 2011 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3690 |