FDA 510(k) Application Details - K021112

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K021112
Device Name Ventilator, Continuous, Facility Use
Applicant EVENT MEDICAL LTD
800 GRAND AVE.
SUITE C3
CARLSBAD, CA 92008 US
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Contact MIKE GRIFFITHS
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 04/05/2002
Decision Date 11/22/2002
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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