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FDA 510(k) Application Details - K133301
Device Classification Name
Plethysmograph, Impedance
More FDA Info for this Device
510(K) Number
K133301
Device Name
Plethysmograph, Impedance
Applicant
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
6412 S. ARVILLE ST.
LAS VEGAS, NV 89118 US
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Contact
MARC O'GRIOFA
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
10/25/2013
Decision Date
01/22/2014
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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