Multi-LinkTM X2 ECG Adapter And Leadwires

Cable, Transducer And Electrode, Patient, (including Connector)

Vyaire Medical, Inc.

The following data is part of a premarket notification filed by Vyaire Medical, Inc. with the FDA for Multi-linktm X2 Ecg Adapter And Leadwires.

Pre-market Notification Details

Device IDK200510
510k NumberK200510
Device Name:Multi-LinkTM X2 ECG Adapter And Leadwires
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa,  IL  60045
ContactSuzanne Moreno
CorrespondentSuzanne Moreno
Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa,  IL  60045
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-10-09

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