K940812 is an FDA 510(k) clearance for the INSIGHT ELECTRONIC ALIGNMENT INDICATOR. This device is classified as a Goniometer, Ac-powered (Class I - General Controls, product code KQX).
Submitted by Andronic Devices, Ltd. (Richmond, B.C. Canada V6v 2j2, CA). The FDA issued a Cleared decision on November 21, 1994, 272 days after receiving the submission on February 22, 1994.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.
| 510(k) Number | K940812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1994 |
| Decision Date | November 21, 1994 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | KQX — Goniometer, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.1500 |