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FDA 510(k) Application Details - K002197
Device Classification Name
Electrocardiograph
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510(K) Number
K002197
Device Name
Electrocardiograph
Applicant
CARDIONICS, INC.
13723 DANA LN. EAST
PUYALLUP, WA 98373 US
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JEFF MORGAN
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Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
07/20/2000
Decision Date
12/27/2000
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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