FDA 510(k) Application Details - K152831

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

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510(K) Number K152831
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SKANRAY TECHNOLOGIES PRIVATE LIMITED
PLOT #360, KIADB INDUSTRIAL AREA, HEBBAL
MYSORE 570018 IN
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Contact MAHADEVAN J
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/29/2015
Decision Date 02/23/2016
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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