FDA 510(k) Application Details - K983717

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

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510(K) Number K983717
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant AEROTEL MEDICAL SYSTEMS (1998) LTD.
5 HATZOREF ST.
HOLON 58856 IL
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Contact GEORGE MYERS
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/21/1998
Decision Date 09/16/1999
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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