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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 K041900
Device Name HC604 CPAP HUMIDIFIER
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
Auckland,  NZ 1701
Applicant Contact JAMES THOMPSON
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
Auckland,  NZ 1701
Correspondent Contact JAMES THOMPSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/14/2004
Decision Date 08/31/2004
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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