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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K171678
Device Name Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
Applicant
Vyaire Medical, Inc.
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Applicant Contact Leo Sohlberg
Correspondent
Vyaire Medical, Inc
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Colleen O'Keefe
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/06/2017
Decision Date 04/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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