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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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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