FDA 510(k) Application Details - K021225

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

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510(K) Number K021225
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ROSSMAX INTERNATIONAL LTD.
12F., NO.189, KANG CHIEN RD.
TAIPEI 114 TW
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Contact MICHAEL YEH
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 04/18/2002
Decision Date 05/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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