FDA 510(k) Application Details - K000237

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

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510(K) Number K000237
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant CYBERCARE, INC.
7840 ROSWELL RD.
SUITE 320
ATLANTA, GA 30350 US
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Contact RICHARD HALBACH
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/27/2000
Decision Date 06/13/2000
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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