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FDA 510(k) Application Details - K093359
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K093359
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
SHANGHAI LITTLE DOCTOR CO. LIMITED
NO. 8 TONGXING ROAD
NANTONG, JIANGSU 26007 CN
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Contact
JANUSUN WANG
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2009
Decision Date
11/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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