Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K940300 |
Device Name |
MAGELLAN |
Applicant |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER, PH.D. |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
LARRY A KROGER, PH.D. |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 01/24/1994 |
Decision Date | 03/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|