Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K031637 |
Device Name |
INNOVA 3100 |
Applicant |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
LARRY KROGER |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/27/2003 |
Decision Date | 08/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|