tremoFlo C-100 Airwave Oscillometry System— 510(k) K170185

Name: FDA 510(k) clearance K170185
Creator: U.S. Food and Drug Administration
Published: 2017-09-12

Substantially Equivalent

Thorasys Thoracic Medical Systems, Inc.

FDA 510(k) clearance K170185 for tremoFlo C-100 Airwave Oscillometry System, Substantially Equivalent on 2017-09-12. 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: 2017-01-23
Decision date: 2017-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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