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FDA 510(k) Application Details - K092558
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K092558
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
HARVARD MEDICAL DEVICES LTD.
39 CHATHAM ROAD SOUTH
TSIMSHATSUI, KOWLOON HK
Other 510(k) Applications for this Company
Contact
MARTIN MA
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
08/20/2009
Decision Date
03/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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