The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Diasonics, Berger Stereotactic Neorobiopsy.
| Device ID | K851973 |
| 510k Number | K851973 |
| Device Name: | DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Flor Fernandez |
| Correspondent | Flor Fernandez DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-07-26 |