The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Universal Service Module.
| Device ID | K851446 |
| 510k Number | K851446 |
| Device Name: | UNIVERSAL SERVICE MODULE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Flor O Fernandez |
| Correspondent | Flor O Fernandez DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-10-31 |