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FDA 510(k) Application Details - K172311
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K172311
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
Biotricity Inc.
275 Shoreline Drive, Suite 150
Redwood City, CA 94065 US
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Contact
Spencer LaDow
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
08/01/2017
Decision Date
12/15/2017
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
Y
Expedited Review
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