FDA 510(k) Application Details - K060077

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

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510(K) Number K060077
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant REAL TONE TECHNOLOGY CORP.
XI HUANG ROAD; XINZHUANG TOWN
SHANGHAI 201110 CN
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Contact TOM WANG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/10/2006
Decision Date 03/08/2006
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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