K140095 is an FDA 510(k) clearance for the PRIME ZOOM STRETCHER. This device is classified as a Stretcher, Wheeled, Powered (Class II — Special Controls, product code INK).
Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on May 20, 2014, 126 days after receiving the submission on January 14, 2014.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K140095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2014 |
| Decision Date | May 20, 2014 |
| Days to Decision | 126 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 |