Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K092308 |
Device Name |
POLESTAR, MODEL N-30 |
Applicant |
MEDTRONIC NAVIGATION ISRAEL, LTD. |
KOCHAV YOKNEAM |
BLDG P.O. BOX 548 |
YOKNEAM ELIT,
IL
20692
|
|
Applicant Contact |
YAIR PENIAS |
Correspondent |
MEDTRONIC NAVIGATION ISRAEL, LTD. |
KOCHAV YOKNEAM |
BLDG P.O. BOX 548 |
YOKNEAM ELIT,
IL
20692
|
|
Correspondent Contact |
YAIR PENIAS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/30/2009 |
Decision Date | 03/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|