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FDA 510(k) Application Details - K042273
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K042273
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
HEALTH HERO NETWORK, INC.
2570 WEST EL CAMINO REAL
SUITE 111
MOUNTAIN VIEW, CA 94040-1309 US
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Contact
GEOFFREY J CLAPP
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Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
08/23/2004
Decision Date
08/31/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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