Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K022372 |
Device Name |
HRH-127-8 HEAD ARRAY COIL |
Applicant |
MRI DEVICES CORP. |
1515 PARAMOUNT DR. |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
TOM SCHUBERT |
Correspondent |
MRI DEVICES CORP. |
1515 PARAMOUNT DR. |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
TOM SCHUBERT |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/22/2002 |
Decision Date | 08/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|