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FDA 510(k) Application Details - K002725
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
More FDA Info for this Device
510(K) Number
K002725
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant
PROTOCOL SYSTEMS, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON, OR 97008-7101 US
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Contact
DON M ABBEY
Other 510(k) Applications for this Contact
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
08/31/2000
Decision Date
11/21/2000
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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