FDA 510(k) Application Details - K101286

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K101286
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant LINDE HEALTHCARE AB
AGAVAGEN 54
LIDINGO SE 18181 SE
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Contact ANDERS PALM
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 05/07/2010
Decision Date 10/20/2011
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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