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FDA 510(k) Application Details - K162571
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K162571
Device Name
Recorder, Magnetic Tape, Medical
Applicant
Biotricity Inc.
75 International Blvd, Suite 300
Toronto M9W 6L9 CA
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Contact
Tom Elias
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Regulation Number
870.2800
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Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
09/15/2016
Decision Date
10/13/2016
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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