K894557 is an FDA 510(k) clearance for the LIGHTSCOPE SET. This device is classified as a Dynamometer, Nonpowered (Class I - General Controls, product code HRW).
Submitted by Optik (Criftib, US). The FDA issued a Cleared decision on August 7, 1989, 18 days after receiving the submission on July 20, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1250.
| 510(k) Number | K894557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1989 |
| Decision Date | August 07, 1989 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HRW — Dynamometer, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.1250 |