The following data is part of a premarket notification filed by Sonomed Technology, Inc. with the FDA for Sonomed Tech Ophthalmic B-scan B-3000.
| Device ID | K844031 |
| 510k Number | K844031 |
| Device Name: | SONOMED TECH OPHTHALMIC B-SCAN B-3000 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-15 |
| Decision Date | 1985-05-22 |