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 |