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 |