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FDA 510(k) Application Details - K041491
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K041491
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ZEWA, INC.
3537 N.W. 115TH AVENUE
MIAMI, FL 33178 US
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Contact
THOMAS ZEINDLER
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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
06/04/2004
Decision Date
09/20/2004
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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