The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Ophthascan B.
| Device ID | K844686 |
| 510k Number | K844686 |
| Device Name: | OPHTHASCAN B |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-09-13 |