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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 K161686
Device Name F&P InfoSmart
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
Auckland,  NZ 2013
Applicant Contact Jayanti Karandikar
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
Auckland,  NZ 2013
Correspondent Contact Jayanti Karandikar
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/17/2016
Decision Date 01/24/2017
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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