The following data is part of a premarket notification filed by American Medical Optics with the FDA for Argon/krypton Laser Photocoagulator Sys.
| Device ID | K843966 |
| 510k Number | K843966 |
| Device Name: | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS |
| Classification | Photocoagulator And Accessories |
| Applicant | AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Contact | Georgia Conrad |
| Correspondent | Georgia Conrad AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-11-08 |