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FDA 510(k) Application Details - K032541
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K032541
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
ODIN MEDICAL TECHNOLOGIES LTD.
P.O BOX 548
YOKNEAM ELIT 20692 IL
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Contact
EINAV SHLOMOVITZ
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
08/18/2003
Decision Date
09/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K032541
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