tremoFlo C-100 Airwave Oscillometry System
K-Number: K170185 · 2017-09-12
Decision Date2017-09-12
Product CodePNV
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
tremoFlo C-100 Airwave Oscillometry System is a medical device manufactured by Thorasys Thoracic Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-09-12 under approval number K170185. 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 C-100 Airwave Oscillometry System?
tremoFlo C-100 Airwave Oscillometry System is a medical device that received FDA 510(k) clearance on 2017-09-12. It is manufactured by Thorasys Thoracic Medical Systems, Inc.. The 510(k) number is K170185.
When was tremoFlo C-100 Airwave Oscillometry System approved by the FDA?
tremoFlo C-100 Airwave Oscillometry System received FDA 510(k) clearance on 2017-09-12, under approval number K170185.
What company makes tremoFlo C-100 Airwave Oscillometry System?
tremoFlo C-100 Airwave Oscillometry System is manufactured by Thorasys Thoracic Medical Systems, Inc..
What is the FDA product code for tremoFlo C-100 Airwave Oscillometry System?
The FDA product code for tremoFlo C-100 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.