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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 K083832
Device Name ZEST NASAL MASK
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
P.O. Box 14348
East Tamaki,  NZ
Applicant Contact TINA MASON
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
P.O. Box 14348
East Tamaki,  NZ
Correspondent Contact TINA MASON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/23/2008
Decision Date 03/16/2009
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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