Submission Details
| 510(k) Number | K771018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 1977 |
| Decision Date | July 14, 1977 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K771018 is an FDA 510(k) clearance for the TRANS 2000, a Stretcher, Wheeled, Powered (Class II — Special Controls, product code INK), submitted by Hamilton Industries, Inc. (Walker, US). The FDA issued a Cleared decision on July 14, 1977, 38 days after receiving the submission on June 6, 1977. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K771018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 1977 |
| Decision Date | July 14, 1977 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3690 |