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FDA 510(k) Application Details - K061123
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K061123
Device Name
Electrocardiograph
Applicant
PARAMA-TECH COMPANY., LTD
1151 HOPE STREET
STAMFORD, CT 06907-1659 US
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Contact
RICHARD KEEN
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2006
Decision Date
06/29/2007
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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