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FDA 510(k)

LTV2 Series Ventilators

K-Number: K201082 · 2021-11-10

ApplicantVyaire Medical, Inc.
Decision Date2021-11-10
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LTV2 Series Ventilators is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K201082. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LTV2 Series Ventilators?

LTV2 Series Ventilators is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K201082.

When was LTV2 Series Ventilators approved by the FDA?

LTV2 Series Ventilators received FDA 510(k) clearance on 2021-11-10, under approval number K201082.

What company makes LTV2 Series Ventilators?

LTV2 Series Ventilators is manufactured by Vyaire Medical, Inc..

What is the FDA product code for LTV2 Series Ventilators?

The FDA product code for LTV2 Series Ventilators is CBK.

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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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