The following data is part of a premarket notification filed by Emory University with the FDA for Emory Cardiac Tool Box.
| Device ID | K980914 |
| 510k Number | K980914 |
| Device Name: | EMORY CARDIAC TOOL BOX |
| Classification | System, Tomography, Computed, Emission |
| Applicant | EMORY UNIVERSITY 1510 CLIFTON RD. N.E. G65 ROLLINS RESEARCH CENTER Atlanta, GA 30322 |
| Contact | Ernest V Garcia |
| Correspondent | Ernest V Garcia EMORY UNIVERSITY 1510 CLIFTON RD. N.E. G65 ROLLINS RESEARCH CENTER Atlanta, GA 30322 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-06-04 |
| Summary: | summary |