Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K032541 |
Device Name |
POLESTAR N-20 |
Applicant |
ODIN MEDICAL TECHNOLOGIES LTD. |
P.O BOX 548 |
YOKNEAM ELIT,
IL
20692
|
|
Applicant Contact |
EINAV SHLOMOVITZ |
Correspondent |
ODIN MEDICAL TECHNOLOGIES LTD. |
P.O BOX 548 |
YOKNEAM ELIT,
IL
20692
|
|
Correspondent Contact |
EINAV SHLOMOVITZ |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/18/2003 |
Decision Date | 09/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|