FDA.reportPublic FDA data

510(k) K211294

Device
Multi-Link X2 ECG Cable and Leadwire System
Applicant
Vyaire Medical, Inc.
510(k) number
K211294
Product code
DSA
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-16
Date received
2021-04-28
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (Including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joshua Davis
Address
26125 N. Riverwoods Blvd. Mettawa IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254114Baylis Connector CableBaylis Medical Technologies, Inc.2026-01-18
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K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2025-05-02
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K222370SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2023-04-02
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