Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K040877 |
Device Name |
ARTOSCAN C |
Applicant |
ESAOTE S.P.A. |
7992 CASTLEWAY DRIVE |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
CARRI GRAHAM |
Correspondent |
ESAOTE S.P.A. |
7992 CASTLEWAY DRIVE |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
CARRI GRAHAM |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 04/05/2004 |
Decision Date | 05/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|