FDA 510(k) Application Details - K130178

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K130178
Device Name Ventilator, Continuous, Facility Use
Applicant EVENT MEDICAL LTD
971CALLE AMANECER
SUITE 101
SAN CLEMENTE, CA 92673 US
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Contact RICK WATERS
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 01/25/2013
Decision Date 10/29/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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