LungTrainer (MD2 & MD3)— 510(k) K221058

Substantially Equivalent

Lung Trainers, LLC

FDA 510(k) clearance K221058 for LungTrainer (MD2 & MD3), Substantially Equivalent on 2023-07-05. Applicant: Lung Trainers, LLC. Device class: 2.

Clearance details

Applicant: Lung Trainers, LLC
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2022-04-11
Decision date: 2023-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.