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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 K201082
Device Name LTV2 Series Ventilators
Applicant
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Applicant Contact Colleen Watson
Correspondent
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Colleen Watson
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/23/2020
Decision Date 11/10/2021
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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