FDA 510(k) Application Details - K013434

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

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510(K) Number K013434
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant COLIN CORP.
2007-1 HAYASHI
KOMAKI CITY, AICHI PREF. 485-8501 JP
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Contact KENICHI SAKURADO
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/16/2001
Decision Date 07/09/2002
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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