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FDA 510(k)

Multi-LinkTM X2 ECG Adapter and Leadwires

K-Number: K200510 · 2020-10-09

ApplicantVyaire Medical, Inc.
Decision Date2020-10-09
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-LinkTM X2 ECG Adapter and Leadwires is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2020-10-09 under approval number K200510. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi-LinkTM X2 ECG Adapter and Leadwires?

Multi-LinkTM X2 ECG Adapter and Leadwires is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K200510.

When was Multi-LinkTM X2 ECG Adapter and Leadwires approved by the FDA?

Multi-LinkTM X2 ECG Adapter and Leadwires received FDA 510(k) clearance on 2020-10-09, under approval number K200510.

What company makes Multi-LinkTM X2 ECG Adapter and Leadwires?

Multi-LinkTM X2 ECG Adapter and Leadwires is manufactured by Vyaire Medical, Inc..

What is the FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires?

The FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires is DSA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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