The following data is part of a premarket notification filed by Sonomed Technology, Inc. with the FDA for Ophthalmic A-scan A-2000 Sonome.
| Device ID | K843696 |
| 510k Number | K843696 |
| Device Name: | OPHTHALMIC A-SCAN A-2000 SONOME |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOMED TECHNOLOGY, INC. 3000 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Louis Katz |
| Correspondent | Louis Katz SONOMED TECHNOLOGY, INC. 3000 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-19 |
| Decision Date | 1985-02-26 |