FDA 510(k) Application Details - K040221

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K040221
Device Name Ventilator, Continuous, Facility Use
Applicant MAQUET CRITICAL CARE AB
186 WOOD AVENUE SOUTH
ISELIN, NJ 08830 US
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Contact JAMIE YIEH
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 02/02/2004
Decision Date 02/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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