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FDA 510(k) Application Details - K010751
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K010751
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
MEDICAL MONITORS PTY LIMITED
166 BELMORE ROAD; SUITE 14
RANDWICK NSW 2031 AU
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Contact
HARRY L PLATT
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Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
03/13/2001
Decision Date
06/11/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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