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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
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