Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K040616 |
Device Name |
CARDIOMD-AC |
Applicant |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
DR. NEERGAARDSVEJ 5F |
HORSHOLM,
DK
|
|
Applicant Contact |
NIELS SORENSEN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
SUSAN GILL |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 03/09/2004 |
Decision Date | 03/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|