The following data is part of a premarket notification filed by Syntermed, Inc. with the FDA for Emory Cardiac Toolbox 4.0.
| Device ID | K123646 |
| 510k Number | K123646 |
| Device Name: | EMORY CARDIAC TOOLBOX 4.0 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SYNTERMED, INC. 245 OWENS DR. Anaheim, CA 92808 |
| Contact | Kenneth Van Train |
| Correspondent | Kenneth 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 | 2012-11-27 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B133ECTB40 | K123646 | 000 |
| B133ECTB422102190 | K123646 | 000 |
| B133ECTB422112080 | K123646 | 000 |
| B133ECTB42221031 | K123646 | 000 |
| B133ECTB42231102 | K123646 | 000 |