FDA 510(k) Application Details - K060194

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K060194
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MARCH HEALTHCARE CORPORATION
555 LEGGET DR, TOWER B
SUITE 222
OTTAWA, ONTARIO K2K 2X3 CA
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Contact TIMON LEDAIN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/25/2006
Decision Date 02/13/2006
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 Y
Expedited Review



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