The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Ar-1100 Automatic Refractor.
Device ID | K861065 |
510k Number | K861065 |
Device Name: | AR-1100 AUTOMATIC REFRACTOR |
Classification | Refractometer, Ophthalmic |
Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
Contact | John Bratkowsky |
Correspondent | John Bratkowsky 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 | 1986-03-20 |
Decision Date | 1986-04-09 |