FDA 510(k) Application Details - K023723

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

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510(K) Number K023723
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant FMS, FINAPRES MEDICAL SYSTEMS BV
1205 DE LA VINA ST.
SANTA BARBARA, CA 93101 US
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Contact CHRISTINE EMANUEL
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 11/05/2002
Decision Date 10/23/2003
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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