FDA 510(k) Application Details - K160665

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K160665
Device Name Gas-Machine, Anesthesia
Applicant MAQUET CRITICAL CARE AB
RONTGENVAGEN 2
SOLNA SE-171 54 SE
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Contact CARINA LUNDBERG
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 03/09/2016
Decision Date 03/29/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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