The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for 5.0 Iop & 7.5 Iop Probes.
| Device ID | K853432 |
| 510k Number | K853432 |
| Device Name: | 5.0 IOP & 7.5 IOP PROBES |
| Classification | Echoencephalograph |
| 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 | GXW |
| CFR Regulation Number | 882.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-15 |
| Decision Date | 1986-02-07 |