Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K050299 |
Device Name |
HRK-123 KNEE ARRAY COIL |
Applicant |
MRI DEVICES CORPORATION |
N27W23676 PAUL RD |
PEWAUKEE,
WI
53072
|
|
Applicant Contact |
TOM SCHUBERT |
Correspondent |
MRI DEVICES CORPORATION |
N27W23676 PAUL RD |
PEWAUKEE,
WI
53072
|
|
Correspondent Contact |
TOM SCHUBERT |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 02/07/2005 |
Decision Date | 02/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|