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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K190853
Device Name Vyntus BODY
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 Number868.1880
Classification Product Code
BZC  
Subsequent Product Codes
BTY   JEH  
Date Received04/02/2019
Decision Date 08/16/2019
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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