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FDA 510(k) Application Details - K945215
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K945215
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
MARS METAL CO., LTD.
5510 SUGAR PINE DR.
YORBA LINDA, CA 92686 US
Other 510(k) Applications for this Company
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
10/25/1994
Decision Date
01/31/1996
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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