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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K832928
Device Name SERVO HEATED RESPIRATORY HUMIDIFIER
Applicant
FISHER & PAYKEL ALLIED PRODUCTS LTD.
P.O. BOX 14-348
PANMURE, NEW ZEALAND,  NZ
Correspondent
FISHER & PAYKEL ALLIED PRODUCTS LTD.
P.O. BOX 14-348
PANMURE, NEW ZEALAND,  NZ
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/24/1983
Decision Date 11/25/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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