The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Monocular Direct Ophthalmoscope.
| Device ID | K844971 |
| 510k Number | K844971 |
| Device Name: | MONOCULAR DIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | John Bratkowsky |
| Correspondent | John Bratkowsky NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-24 |
| Decision Date | 1985-02-15 |