tremoflo C2 Airwave Oscillometry System

FDA 510(k) K221024 · Thorasys Thoracic Medical Systems, Inc.

Substantially Equivalent

510(k) numberK221024

Submission

Device name
tremoflo C2 Airwave Oscillometry System
Applicant
Thorasys Thoracic Medical Systems, Inc.
Montreal, CA
Received
April 6, 2022
Decision date
June 20, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PNV – Impedance Measuring Device Utilizing Oscillation Techniques
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

This device measures respiratory impedance.

Other 510(k)s with product code PNV

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K191876PulmoScanPNV · Traditional Cognita Labs, LLC03/18/2020SE
K170185tremoFlo C-100 Airwave Oscillometry SystemPNV · Traditional Thorasys Thoracic Medical Systems, Inc.09/12/2017SE
K152585Resmon PRO FULLPNV · Traditional Medical Graphics Corp.06/24/2016SE

More from Medical Graphics Corp.

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K170185tremoFlo C-100 Airwave Oscillometry SystemPNV · Traditional 09/12/2017SE

Questions and answers

When was tremoflo C2 Airwave Oscillometry System cleared by the FDA?

tremoflo C2 Airwave Oscillometry System (K221024) received a 510(k) decision of Substantially Equivalent on June 20, 2023, 440 days after the submission was received.

What is the product code of K221024?

The FDA product code is PNV – Impedance Measuring Device Utilizing Oscillation Techniques, a Class II (moderate risk) device regulated under 21 CFR 868.1840.