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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 K200089
Device Name F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
Applicant
Fisher & Paykel Healthcare Ltd.
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Healthcare Ltd.
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/15/2020
Decision Date 06/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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