The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Lm-850 Automatic Lensmeter.
Device ID | K861064 |
510k Number | K861064 |
Device Name: | LM-850 AUTOMATIC LENSMETER |
Classification | Instrument, Measuring, Lens, 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 | HLM |
CFR Regulation Number | 886.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-20 |
Decision Date | 1986-04-15 |