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510(k) K221024

Device
tremoflo C2 Airwave Oscillometry System
Applicant
Thorasys Thoracic Medical Systems, Inc.
510(k) number
K221024
Product code
PNV
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-20
Date received
2022-04-06
Regulation
868.1840
Classification name
Impedance Measuring Device Utilizing Oscillation Techniques
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Paul Donnelly
Address
6560 Ave. De L'Esplanade Suite #103 Montreal CA H2V 4L5 H2V 4L5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191876PulmoScanCognita Labs, LLC2020-03-18
K170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.2017-09-12
K152585Resmon PRO FULLMedical Graphics Corp.2016-06-24