The following data is part of a premarket notification filed by Syntermed, Inc. with the FDA for Emory Cardiac Toolbox 2.1 Executing On Nuclear Medicine Computers.
| Device ID | K014033 |
| 510k Number | K014033 |
| Device Name: | EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SYNTERMED, INC. 245 OWENS DR. Anaheim, CA 92808 |
| Contact | Kenneth F Van Train |
| Correspondent | Kenneth F Van Train SYNTERMED, INC. 245 OWENS DR. Anaheim, CA 92808 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-02-22 |
| Summary: | summary |