Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K791830 |
Device Name |
L/U ARM - NEURO - VASCULAR #B5080B |
Applicant |
GENERAL ELECTRIC CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GENERAL ELECTRIC CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 09/17/1979 |
Decision Date | 10/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|