FDA 510(k) Application Details - K051539

Device Classification Name Blood Pressure Cuff

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510(K) Number K051539
Device Name Blood Pressure Cuff
Applicant YA HORNG ELECTRONIC CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 30067 TW
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Contact JEN KE-MIN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 06/10/2005
Decision Date 08/05/2005
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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