The following data is part of a premarket notification filed by American Medical Optics with the FDA for American Medical Optics Imaging Sys.
| Device ID | K842127 |
| 510k Number | K842127 |
| Device Name: | AMERICAN MEDICAL OPTICS IMAGING SYS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | AMERICAN MEDICAL OPTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-29 |
| Decision Date | 1984-09-07 |