Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K051460 |
Device Name |
C.CAM-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 |
JEFFREY D RONGERO |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 06/03/2005 |
Decision Date | 06/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|