FDA 510(k) Application Details - K030561

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

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510(K) Number K030561
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MYTECH TECHNOLOGY CO., LTD.
2064 TAMARIN DR.
COLUMBUS, OH 43235 US
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Contact SHU CHEN CHENG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 02/21/2003
Decision Date 05/09/2003
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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