Decision Date2019-09-13
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Multi-Link X2 ECG and SpO2 Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) 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. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K191273.
When did Multi-Link X2 ECG and SpO2 Adapter receive FDA 510(k) clearance?
Multi-Link X2 ECG and SpO2 Adapter received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191273.
Who is the listed applicant for Multi-Link X2 ECG and SpO2 Adapter?
The FDA 510(k) record lists Vyaire Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Vyaire Medical, 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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Official Source
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