The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for 100-01778-52 Ultrasound System.
| Device ID | K882478 |
| 510k Number | K882478 |
| Device Name: | 100-01778-52 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Charles A Kanter |
| Correspondent | Charles A Kanter 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 | 1988-06-16 |
| Decision Date | 1988-10-12 |