FDA 510(k) Application Details - K110044

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

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510(K) Number K110044
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant FORA CARE INC.
3F, 5F, 6F, NO.127, WUGONG
2ND RD., WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact TELING HSU
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/06/2011
Decision Date 07/07/2011
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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