The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Ophthascan Mini-b.
| Device ID | K884595 |
| 510k Number | K884595 |
| Device Name: | OPHTHASCAN MINI-B |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-03 |
| Decision Date | 1989-01-03 |