FDA 510(k) Application Details - K032308

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

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510(K) Number K032308
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MEDITEK TECHNOLOGY, INC.
NO. 5, ALLEY 5, LN CHENG HSING
CHUNG CHING RD.
PEI TUN DIST., TAICHUNG TW
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Contact TONY C.S. CHANG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 07/25/2003
Decision Date 11/10/2003
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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