FDA 510(k) Application Details - K042768

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

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510(K) Number K042768
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant IMETRIKUS, INC.
16787 BERNARDO CENTER DRIVE
SUITE A-1
SAN DIEGO, CA 92128 US
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Contact DANIEL P OLIVIER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/05/2004
Decision Date 02/22/2005
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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