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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 ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Applicant Contact DAVID MILBURN
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
25 CARBINE ROAD 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
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