The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Handy.
Device ID | K973218 |
510k Number | K973218 |
Device Name: | NIDEK HANDY |
Classification | Camera, Ophthalmic, Ac-powered |
Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Contact | Ken Kato |
Correspondent | Ken Kato NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Product Code | HKI |
CFR Regulation Number | 886.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-04 |