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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 the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) 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. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K201082.

When did LTV2 Series Ventilators receive FDA 510(k) clearance?

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

Who is the listed applicant for LTV2 Series Ventilators?

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 LTV2 Series Ventilators?

The FDA product code for LTV2 Series Ventilators is CBK.

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Related Devices (Code: CBK)

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

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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