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FDA 510(k) Application Details - K141872
Device Classification Name
Device, Galvanic Skin Response Measurement
More FDA Info for this Device
510(K) Number
K141872
Device Name
Device, Galvanic Skin Response Measurement
Applicant
IMPETO MEDICAL INC
400 N. WASHINGTON ST., STE 100
MEDICAL DEVICES DIVISION
ALEXANDRIA, VA 22314 US
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Contact
Calley Herzog
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Regulation Number
882.1540
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Classification Product Code
GZO
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More FDA Info for this Product Code
Date Received
07/11/2014
Decision Date
11/21/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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