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FDA 510(k) Application Details - K160064
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K160064
Device Name
Detector And Alarm, Arrhythmia
Applicant
INFOBIONIC, INC.
600 SUFFOLK STREET
LOWELL, MA 01854 US
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Contact
NANCY BRIEFS
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
01/13/2016
Decision Date
03/11/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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