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FDA 510(k) Application Details - K012763
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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510(K) Number
K012763
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA, CO 80004 US
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Contact
LYNNE LEONARD
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Regulation Number
870.2300
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Classification Product Code
DRT
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Date Received
08/17/2001
Decision Date
11/15/2001
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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