FDA 510(k) Application Details - K112114

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K112114
Device Name Gas-Machine, Anesthesia
Applicant MAQUET CRITICAL CARE AB
45 BARBOUR POND DRIVE
WAYNE, NJ 07470 US
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Contact WHITNEY TORNING
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 07/25/2011
Decision Date 01/13/2012
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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