The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Km-800 Auto Keratometer.
Device ID | K861063 |
510k Number | K861063 |
Device Name: | NIDEK KM-800 AUTO KERATOMETER |
Classification | Keratoscope, Ac-powered |
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 | HLQ |
CFR Regulation Number | 886.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-20 |
Decision Date | 1986-04-04 |