The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Saca, 3.5 Mhz Probe.
| Device ID | K905200 |
| 510k Number | K905200 |
| Device Name: | SACA, 3.5 MHZ PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1992-04-02 |