The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Non-mydriatic Fundus Camera, Model Nm-1000.
| Device ID | K014274 |
| 510k Number | K014274 |
| Device Name: | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-04-17 |
| Summary: | summary |