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FDA 510(k) Application Details - K002742
Device Classification Name
Computer, Blood-Pressure
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510(K) Number
K002742
Device Name
Computer, Blood-Pressure
Applicant
PWV MEDICAL PTY, LT.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact
KIRSTEN H PAULSON
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Regulation Number
870.1110
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Classification Product Code
DSK
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More FDA Info for this Product Code
Date Received
09/01/2000
Decision Date
05/01/2001
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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