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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
Predetermined Change
Control Plan Authorized		 No
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