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FDA 510(k) Application Details - K022783
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K022783
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
TENSYS MEDICAL, INC.
5825 OBERLIN DR.
SUITE 100
SAN DIEGO, CA 92121 US
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Contact
STUART L GALLANT
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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
08/22/2002
Decision Date
11/19/2002
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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