FDA 510(k) Application Details - K043352

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

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510(K) Number K043352
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant GOCANNING TECHNOLOGY LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/06/2004
Decision Date 03/31/2005
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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