The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Diasonics Spa 3.5 Mhz, 30mm Probe.
| Device ID | K864812 |
| 510k Number | K864812 |
| Device Name: | DIASONICS SPA 3.5 MHZ, 30MM PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Gary M Agatep |
| Correspondent | Gary M Agatep 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 | 1986-12-09 |
| Decision Date | 1987-03-10 |