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510(k) K221024

tremoflo C2 Airwave Oscillometry System by Thorasys Thoracic Medical Systems, Inc. — Product Code PNV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 20, 2023
Date Received: April 6, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Impedance Measuring Device Utilizing Oscillation Techniques
Device Class: Class II
Regulation Number: 868.1840
Review Panel: AN
Submission Type

This device measures respiratory impedance.