Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K801320 |
Device Name |
SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 |
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 | 06/03/1980 |
Decision Date | 07/21/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|