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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 K121597
Device Name ESON NASAL MASK
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland,  NZ 2013
Applicant Contact JAMES THOMPSON
Correspondent
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland,  NZ 2013
Correspondent Contact JAMES THOMPSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/31/2012
Decision Date 10/02/2012
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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