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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 K040941
Device Name CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 1701
Applicant Contact JAMES THOMPSON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 1701
Correspondent Contact JAMES THOMPSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/12/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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