The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Panoret, Model 1000a.
| Device ID | K001111 |
| 510k Number | K001111 |
| Device Name: | PANORET, MODEL 1000A |
| Classification | Retinoscope, Ac-powered |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Product Code | HKL |
| CFR Regulation Number | 886.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-06 |
| Decision Date | 2000-07-07 |