FDA 510(k) Application Details - K033397

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

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510(K) Number K033397
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant AVITA CORPORATION
9F, NO. 78, SEC. 1,
KWANG-FU RD.
SAN-CHUNG, TAIPEI COUNTY 241 TW
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Contact GEO LIN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/24/2003
Decision Date 04/09/2004
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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