FDA 510(k) Application Details - K993460

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

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510(K) Number K993460
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ROSSMAX INTERNATIONAL LTD.
2F. NO. 8, ALLEY 20 LANE 106
SECTION 3, NAN KANG ROAD
TAIPEI 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 10/13/1999
Decision Date 01/11/2000
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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