The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Ark-2000.
Device ID | K882191 |
510k Number | K882191 |
Device Name: | NIDEK ARK-2000 |
Classification | Refractometer, Ophthalmic |
Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
Contact | Ken Kato |
Correspondent | Ken Kato NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
Product Code | HKO |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-24 |
Decision Date | 1988-07-01 |