The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Cardiac Review Station.
| Device ID | K812515 |
| 510k Number | K812515 |
| Device Name: | CARDIAC REVIEW STATION |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | DIASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-02 |
| Decision Date | 1981-10-02 |