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FDA 510(k) Application Details - K001948
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K001948
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
HYPERTENSION DIAGNOSTICS, INC.
2915 WATERS RD.
SUITE 108
EAGAN, MN 55121-1562 US
Other 510(k) Applications for this Company
Contact
CHARLES F CHESNEY
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2000
Decision Date
11/01/2000
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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