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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 K100011
Device Name FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI,  NZ
Applicant Contact ROBERT PETRY
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI,  NZ
Correspondent Contact ROBERT PETRY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/04/2010
Decision Date 10/08/2010
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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