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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 K162738
Device Name Puritan Bennett 980 Ventilator System
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Kelsey Lee
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Kelsey Lee
Regulation Number868.5895
Classification Product Code
Date Received09/30/2016
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls