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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 K193056
Device Name Puritan Bennett 980 Series Ventilator System
Covidien, LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Zheng Liu
Covidien, LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Zheng Liu
Regulation Number868.5895
Classification Product Code
Date Received11/01/2019
Decision Date 11/20/2020
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