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FDA 510(k) Application Details - K062068
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K062068
Device Name
Electrocardiograph
Applicant
INTELWAVE, LLC
1090 KING GEORGES POST ROAD
SUITE 1004
EDISON, NJ 08837 US
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Contact
ALEXANDER RIFTINE
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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
07/21/2006
Decision Date
10/27/2006
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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