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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K151252
Device Name Puritan Bennett 840 Series Ventilator System
Applicant
Covidien LP
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Kelsey Lee
Correspondent
Covidien LP
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Kelsey Lee
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/12/2015
Decision Date 03/29/2016
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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