FDA 510(k) Application Details - K881970

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

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510(K) Number K881970
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant FISHER & PAYKEL HEALTHCARE, LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND NZ
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Contact DAVID MILBURN
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 05/11/1988
Decision Date 03/09/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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