Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K010850 |
Device Name |
POLESTAR N-10 |
Applicant |
ODIN MEDICAL TECHNOLOGIES LTD. |
P.O. BOX 248 |
YOKNEAM ELIT,
IL
20692
|
|
Applicant Contact |
ADI ICKOWICZ |
Correspondent |
ODIN MEDICAL TECHNOLOGIES LTD. |
P.O. BOX 248 |
YOKNEAM ELIT,
IL
20692
|
|
Correspondent Contact |
ADI ICKOWICZ |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/21/2001 |
Decision Date | 12/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|