Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K031871 |
Device Name |
AUTOBONE |
Applicant |
GE MEDICAL SYSTEMS EUROPE |
283, RUE DE LA MINIERE, B.P.34 |
BUC CEDEX,
FR
78533
|
|
Applicant Contact |
LARRY KROGER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
WOLFRAM GMELIN |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/17/2003 |
Decision Date | 06/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|