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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 K881970
Device Name MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
Applicant
Fisher & Paykel Healthcare, Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Applicant Contact DAVID MILBURN
Correspondent
Fisher & Paykel Healthcare, 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 Received05/11/1988
Decision Date 03/09/1989
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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