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FDA 510(k) Application Details - K141615
Device Classification Name
Computer, Blood-Pressure
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510(K) Number
K141615
Device Name
Computer, Blood-Pressure
Applicant
ENDOPHYS, INC.
755 N. MATHILDA, AVE.
SUITE 100
SUNNYVALE, CA 94085 US
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Contact
RONALD S WARREN
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Regulation Number
870.1110
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Classification Product Code
DSK
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More FDA Info for this Product Code
Date Received
06/16/2014
Decision Date
01/07/2015
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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