tremoflo C2 Airwave Oscillometry System
K-Number: K221024 · 2023-06-20
Decision Date2023-06-20
Product CodePNV
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
tremoflo C2 Airwave Oscillometry System is a medical device manufactured by Thorasys Thoracic Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-06-20 under approval number K221024. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the tremoflo C2 Airwave Oscillometry System?
tremoflo C2 Airwave Oscillometry System is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Thorasys Thoracic Medical Systems, Inc.. The 510(k) number is K221024.
When was tremoflo C2 Airwave Oscillometry System approved by the FDA?
tremoflo C2 Airwave Oscillometry System received FDA 510(k) clearance on 2023-06-20, under approval number K221024.
What company makes tremoflo C2 Airwave Oscillometry System?
tremoflo C2 Airwave Oscillometry System is manufactured by Thorasys Thoracic Medical Systems, Inc..
What is the FDA product code for tremoflo C2 Airwave Oscillometry System?
The FDA product code for tremoflo C2 Airwave Oscillometry System is PNV.
Other Devices by Thorasys Thoracic Medical Systems, Inc.
Related Devices (Code: PNV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.