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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K191273
Device Name Multi-Link X2 ECG and SpO2 Adapter
Applicant
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60630
Applicant Contact Suzanne Moreno
Correspondent
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60630
Correspondent Contact Suzanne Moreno
Regulation Number870.2900
Classification Product Code
DSA  
Subsequent Product Code
DQA  
Date Received05/13/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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