FDA 510(k) Application Details - K983855

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

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510(K) Number K983855
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant JAWON MEDICAL CO., LTD.
1208-12 SINGSANG-LI, JINRYANG
MYUN
KYUNGSAN-CITY, KUNGSANG-BUKDO KR
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 11/02/1998
Decision Date 11/17/1998
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 Y
Expedited Review



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