The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Oct-opthalmoscope.
| Device ID | K042885 |
| 510k Number | K042885 |
| Device Name: | OCT-OPTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2005-01-21 |
| Summary: | summary |