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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K133666
Device Name RT016 INSPIRATORY FILTER
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Applicant Contact ELIZABETH GOLDSTEIN
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Correspondent Contact ELIZABETH GOLDSTEIN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received11/29/2013
Decision Date 02/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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