The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Diasonics Transvaginal, Tv 7.5 Mhz Probe.
| Device ID | K864908 |
| 510k Number | K864908 |
| Device Name: | DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE |
| Classification | Transducer, Ultrasonic, Obstetric |
| 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 | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-03-27 |