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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
East Tamaki,  NZ 2013
Applicant Contact Jayanti Karandikar
Correspondent
FISHER & PAYKEL HEALTHCARE LTD.
15 MAURICE PAYKEL PLACE
East Tamaki,  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
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