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FDA 510(k) Application Details - K060925
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K060925
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact
EDWARD TUNG
Other 510(k) Applications for this Contact
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
04/04/2006
Decision Date
05/09/2006
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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