The following data is part of a premarket notification filed by Ophthalmos Ltd. with the FDA for Optyse Ophthalmoscope.
| Device ID | K061278 |
| 510k Number | K061278 |
| Device Name: | OPTYSE OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | OPHTHALMOS LTD. UNIT 1 ABBEY BARNS DUXFORD ROAD Ickleton, Cambridge, GB Cb10 1sx |
| Contact | Laura J Garcia |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-05-16 |
| Summary: | summary |