The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Cv-12000.
Device ID | K924260 |
510k Number | K924260 |
Device Name: | NIDEK CV-12000 |
Classification | Unit, Phacofragmentation |
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 | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-03-26 |