FDA 510(k)

Multi-Link X2 ECG Cable and Lead Wire System

K-Number: K162432 · 2017-01-18

Decision Date2017-01-18

Product CodeDSA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Multi-Link X2 ECG Cable and Lead Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K162432. 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-Link X2 ECG Cable and Lead Wire System?

Multi-Link X2 ECG Cable and Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K162432.

When did Multi-Link X2 ECG Cable and Lead Wire System receive FDA 510(k) clearance?

Multi-Link X2 ECG Cable and Lead Wire System received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162432.

Who is the listed applicant for Multi-Link X2 ECG Cable and Lead Wire System?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Link X2 ECG Cable and Lead Wire System?

The FDA product code for Multi-Link X2 ECG Cable and Lead Wire System is DSA.

Related Clinical Trials

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NCT07775976Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care PathwaysENROLLING_BY_INVITATION

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Related Devices (Code: DSA)

Official Source

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