tremoflo C2 Airwave Oscillometry System— 510(k) K221024

Name: FDA 510(k) clearance K221024
Creator: U.S. Food and Drug Administration
Published: 2023-06-20

Substantially Equivalent

Thorasys Thoracic Medical Systems, Inc.

FDA 510(k) clearance K221024 for tremoflo C2 Airwave Oscillometry System, Substantially Equivalent on 2023-06-20. Applicant: Thorasys Thoracic Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Thorasys Thoracic Medical Systems, Inc.
Product code: Code PNV
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2022-04-06
Decision date: 2023-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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