The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Clinical Diagnostic Software.
| Device ID | K970288 |
| 510k Number | K970288 |
| Device Name: | CLINICAL DIAGNOSTIC SOFTWARE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NUCCARDIAC SOFTWARE, INC. 5955 VIA DEL TECOLOTE Yorba Linda, CA 92686 |
| Contact | Kenneth F Vann Train |
| Correspondent | Kenneth F Vann Train NUCCARDIAC SOFTWARE, INC. 5955 VIA DEL TECOLOTE Yorba Linda, CA 92686 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-24 |
| Summary: | summary |