Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K013422 |
Device Name |
CARDIQ FUNCTION |
Applicant |
GE MEDICAL SYSTEMS |
3200 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
STEVEN J KACHELMEYER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
REINER KRUMME |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 10/15/2001 |
Decision Date | 10/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|