K894283 is an FDA 510(k) clearance for the COMPREHENSIVE SPINE MOTION ANALYZER. This device is classified as a Goniometer, Ac-powered (Class I - General Controls, product code KQX).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 19, 1990, 210 days after receiving the submission on June 23, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.
| 510(k) Number | K894283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1989 |
| Decision Date | January 19, 1990 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | KQX — Goniometer, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.1500 |