The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Argon Laser Photocoagulator Sys Repeat Mode.
Device ID | K844198 |
510k Number | K844198 |
Device Name: | ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE |
Classification | Photocoagulator And Accessories |
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 | HQB |
CFR Regulation Number | 886.4690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-30 |
Decision Date | 1984-12-24 |