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FDA 510(k) Application Details - K150095
Device Classification Name
Plethysmograph, Impedance
More FDA Info for this Device
510(K) Number
K150095
Device Name
Plethysmograph, Impedance
Applicant
SENSIBLE MEDICAL INNOVATIONS LTD.
4 HAALON ST. KEFAR NETER
POB 8702
NETANYA 4059300 IL
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Contact
Inbal Ben-Tzvi
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
DSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/2015
Decision Date
08/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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