FDA 510(k) Application Details - K133886

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K133886
Device Name Gas-Machine, Anesthesia
Applicant DRAEGER MEDICAL GMBH
6 TECH DRIVE
ANDOVER, MA 01810 US
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Contact BETH ZIS
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 12/20/2013
Decision Date 06/20/2014
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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