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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 K983112
Device Name RESPIRATORY HUMIDIFIER, MODEL # MR850
Applicant
Fisher &Paykel Healthcare , Ltd.
Healthcare Div.
25 Carbine Rd.
Auckland,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Fisher &Paykel Healthcare , Ltd.
Healthcare Div.
25 Carbine Rd.
Auckland,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/04/1998
Decision Date 11/10/1998
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
Recalls CDRH Recalls
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