FDA 510(k) Application Details - K031327

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

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510(K) Number K031327
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant CVP DIAGNOSTICS, INC.
2305 GOLD MINE RD.
BROOKEVILLE, MD 20833 US
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Contact T. WHIT ATHEY
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 04/25/2003
Decision Date 05/12/2004
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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