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FDA 510(k) Application Details - K063044
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K063044
Device Name
Electrode, Electrocardiograph
Applicant
MONEBO TECHNOLOGIES, INC.
1800 BARTON CREEK BLVD.
AUSTIN, TX 78735-1606 US
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Contact
DALE J MISCZYNSKI
Other 510(k) Applications for this Contact
Regulation Number
870.2360
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Classification Product Code
DRX
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More FDA Info for this Product Code
Date Received
10/04/2006
Decision Date
03/23/2007
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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