Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K000221 |
Device Name |
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM |
Applicant |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
TED L PARROT |
Correspondent |
GE DEC MEDICAL SYSTEMS |
P.O. Box 7550 |
Madison,
WI
53707
|
|
Correspondent Contact |
Monica Morrison |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/24/2000 |
Decision Date | 04/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|