Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K050489 |
Device Name |
INNOVA 2100 |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/25/2005 |
Decision Date | 03/11/2005 |
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
|
|
|