The following data is part of a premarket notification filed by Syntermed, Inc. with the FDA for Emory Cardiac Toolbox Version 2.6.
| Device ID | K040141 |
| 510k Number | K040141 |
| Device Name: | EMORY CARDIAC TOOLBOX VERSION 2.6 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SYNTERMED, INC. 3340 PEACHTREE RD NE SUITE 1800 Atlanta, GA 30326 |
| Contact | Kenneth F Van Train |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-22 |
| Decision Date | 2004-01-30 |
| Summary: | summary |