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FDA 510(k) Application Details - K093923
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K093923
Device Name
Oximeter, Tissue Saturation
Applicant
OR-NIM MEDICAL LTD.
1 YODFAT ST
LOD 71291 IL
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Contact
MICHAL BALBERG, PHD
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
MUD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
01/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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