Device Classification Name |
generator, high-voltage, x-ray, diagnostic
|
510(k) Number |
K943652 |
Device Name |
VASCULAR MP X-RAY GENERATOR |
Applicant |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER, PH.D. |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
LARRY A KROGER, PH.D. |
Regulation Number | 892.1700
|
Classification Product Code |
|
Date Received | 07/28/1994 |
Decision Date | 08/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|