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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 K073706
Device Name RESPIRATORY HUMIDIFIER, MODEL MR850
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Applicant Contact ADELE BINDON
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Correspondent Contact ADELE BINDON
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/31/2007
Decision Date 03/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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