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FDA 510(k)

Multi-Link X2 ECG and SpO2 Adapter

K-Number: K191273 · 2019-09-13

ApplicantVyaire Medical, Inc.
Decision Date2019-09-13
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-Link X2 ECG and SpO2 Adapter is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K191273. 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 and SpO2 Adapter?

Multi-Link X2 ECG and SpO2 Adapter is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K191273.

When was Multi-Link X2 ECG and SpO2 Adapter approved by the FDA?

Multi-Link X2 ECG and SpO2 Adapter received FDA 510(k) clearance on 2019-09-13, under approval number K191273.

What company makes Multi-Link X2 ECG and SpO2 Adapter?

Multi-Link X2 ECG and SpO2 Adapter is manufactured by Vyaire Medical, Inc..

What is the FDA product code for Multi-Link X2 ECG and SpO2 Adapter?

The FDA product code for Multi-Link X2 ECG and SpO2 Adapter 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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