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FDA 510(k) Application Details - K091434
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K091434
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
TRULY INSTRUMENT CO., LTD.
TRULY INDUSTRICAL AREA
SHANWEI SHI, GUANG DONG 516600 CN
Other 510(k) Applications for this Company
Contact
YANGJIAN HAO
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
05/13/2009
Decision Date
09/04/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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