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FDA 510(k) Application Details - K101123
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K101123
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
BMEYE B.V.
220 RIVER ROAD
CLAREMONT, NH 03743 US
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Contact
WILLIAM F GREENROSE
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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
04/22/2010
Decision Date
10/28/2010
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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