K001111 is an FDA 510(k) clearance for the PANORET, MODEL 1000A. This device is classified as a Retinoscope, Ac-powered (Class II - Special Controls, product code HKL).
Submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 7, 2000, 92 days after receiving the submission on April 6, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1780.
| 510(k) Number | K001111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2000 |
| Decision Date | July 07, 2000 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKL - Retinoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1780 |