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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 K863377
Device Name MR338 SERVO HEATED DELIVERY HUMIDIFIER
Applicant
Fisher & Paykel Allied Products , Ltd.
25 Carbine Rd., Panmure
P.O. Box 14-348, Panmure
Auckland, New Zealand,  NZ
Applicant Contact DAVID MILBURN
Correspondent
Fisher & Paykel Allied Products , Ltd.
25 Carbine Rd., Panmure
P.O. Box 14-348, Panmure
Auckland, New Zealand,  NZ
Correspondent Contact DAVID MILBURN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/03/1986
Decision Date 02/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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