The following data is part of a premarket notification filed by Medibell Medical Vision Technologies Ltd. with the FDA for Panoret, Model Pnm 60.
| Device ID | K040325 |
| 510k Number | K040325 |
| Device Name: | PANORET, MODEL PNM 60 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. MATAM HIGHT TECHNOLOGIES CTR Haifa, IL 31905 |
| Contact | Dan Laor |
| Correspondent | Dan Laor MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. MATAM HIGHT TECHNOLOGIES CTR Haifa, IL 31905 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-10 |
| Decision Date | 2004-03-08 |
| Summary: | summary |