FDA 510(k) Application Details - K990807

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

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510(K) Number K990807
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HEALTH & LIFE CO., LTD.
4F-3, NO. 351, CHUNG SHAN RD.
SEC.02, CHUNG HO CITY
TAIPEI HSIEN TW
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Contact SUSAN CHEN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/11/1999
Decision Date 12/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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