Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K080098 |
Device Name |
MRJ EXTENDED |
Applicant |
PARAMED SRL |
39 HIGH STREET |
NORTH ANDOVER,
MA
01845
|
|
Applicant Contact |
MICHAEL A DOUGLAS |
Correspondent |
PARAMED SRL |
39 HIGH STREET |
NORTH ANDOVER,
MA
01845
|
|
Correspondent Contact |
MICHAEL A DOUGLAS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/14/2008 |
Decision Date | 03/10/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|