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FDA 510(k)

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

K-Number: K163316 · 2017-06-22

ApplicantCarefusion 303, Inc.
Decision Date2017-06-22
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K163316. 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 Adapter and Direct Connect Lead Wire System?

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K163316.

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

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System received FDA 510(k) clearance on 2017-06-22, under 510(k) number K163316.

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

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Other records listing Carefusion 303, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DSA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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