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FDA 510(k)

LungTrainer (MD2 & MD3)

K-Number: K221058 · 2023-07-05

ApplicantLung Trainers, LLC
Decision Date2023-07-05
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LungTrainer (MD2 & MD3) is the device name listed in this FDA 510(k) record. The listed applicant is Lung Trainers, LLC. It received FDA 510(k) clearance on 2023-07-05 under 510(k) number K221058. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungTrainer (MD2 & MD3)?

LungTrainer (MD2 & MD3) is a medical device that received FDA 510(k) clearance on 2023-07-05. The listed applicant is Lung Trainers, LLC. The 510(k) number is K221058.

When did LungTrainer (MD2 & MD3) receive FDA 510(k) clearance?

LungTrainer (MD2 & MD3) received FDA 510(k) clearance on 2023-07-05, under 510(k) number K221058.

Who is the listed applicant for LungTrainer (MD2 & MD3)?

The FDA 510(k) record lists Lung Trainers, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LungTrainer (MD2 & MD3)?

The FDA product code for LungTrainer (MD2 & MD3) is BWF.

Related Devices (Code: BWF)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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