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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 Pl.
East Tamaki, Auckland,  NZ
Applicant Contact ROBERT PETRY
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
East Tamaki, Auckland,  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
Predetermined Change
Control Plan Authorized		 No
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