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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K953949
Device Name HUMIDIFIER & ACCESSORIES
Applicant
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Applicant Contact ADELE YEE
Correspondent
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Correspondent Contact ADELE YEE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/22/1995
Decision Date 10/16/1995
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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