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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 K130328
Device Name F&P SIMPLUS FULL FACE MASK
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Pl.
East Tamaki
Auckland,  NZ 2013
Applicant Contact SUE CHO
Correspondent
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Pl.
East Tamaki
Auckland,  NZ 2013
Correspondent Contact SUE CHO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/11/2013
Decision Date 06/05/2013
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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