FDA 510(k) Application Details - K822816

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

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510(K) Number K822816
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant FISHER & PAYKEL ALLIED PRODUCTS LTD.

, US
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 09/20/1982
Decision Date 10/22/1982
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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