K941705 is an FDA 510(k) clearance for the NERVE FIBER ANALYZER. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Carl Zeiss Meditec, Inc. (San Diego, US). The FDA issued a Cleared decision on July 18, 1994, 103 days after receiving the submission on April 6, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K941705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1994 |
| Decision Date | July 18, 1994 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |