FDA 510(k) Application Details - K051149

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

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510(K) Number K051149
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MEDITECH KFT.
INDUSTRIAL PARK 13
MIZPE AVIV
M.P. MISGAV 20187 IL
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Contact BENNY ARAZY
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 05/04/2005
Decision Date 11/18/2005
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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