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FDA 510(k) Application Details - K151781
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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510(K) Number
K151781
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant
IVY BIOMEDICAL SYSTEMS INC.
11 BUSINESS PARK DRIVE
BRANFORD, CT 06405 US
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Contact
DICK LISTRO
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Regulation Number
870.2300
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Classification Product Code
DRT
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More FDA Info for this Product Code
Date Received
07/01/2015
Decision Date
05/27/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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