FDA 510(k) Application Details - K160764

Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)

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510(K) Number K160764
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant CAREFUSION 2200, INC.
75 N. FAIRWAY DR.
VERNON HILLS, IL 60061 US
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Contact ERIKA FERNANDEZ
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 03/21/2016
Decision Date 08/25/2016
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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