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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 K153505
Device Name F&P Eson 2 Nasal 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 Received12/07/2015
Decision Date 09/20/2016
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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