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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K973161
Device Name CPAP HUMIDIFIER (HC 200)
Applicant
Fisher & Paykel Electronics , Ltd.
Healthcare Div.
25 Carbine Rd., P.O. Box 14348
Auckland,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Fisher & Paykel Electronics , Ltd.
Healthcare Div.
25 Carbine Rd., P.O. Box 14348
Auckland,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/22/1997
Decision Date 07/10/1998
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
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