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 |