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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 K913368
Device Name MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
Applicant
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Applicant Contact RICHARD BELGRAVE
Correspondent
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Correspondent Contact RICHARD BELGRAVE
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/24/1991
Decision Date 01/13/1992
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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