Product code PNV
- Device name
- Impedance Measuring Device Utilizing Oscillation Techniques
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1840
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This device measures respiratory impedance.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| K191876 | PulmoScan | Cognita Labs, LLC | 2020-03-18 |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 07540261016646 | tf C2 Sensor Module - clearflo | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261017117 | tremoflo C2 Device - clearflo | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261019470 | tremoflo C2 Reference Test Load | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261020360 | tremoflo C2 Airwave Oscillometry System and Accessories | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261022333 | tF C2 Sensor Module Labelled - Eco BVF | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261022371 | tremoflo C2 Device - Yellow - VTG 28554 | Thorasys Thoracic Medical Systems Inc | 2025-08-06 |
| 07540261017612 | tf C-100 Kit Vitalograph - Clinical Trial Edition (28300) | Thorasys Thoracic Medical Systems Inc | 2024-09-20 |
| 07540261020698 | tF Calibrated Reference Load 15cmH2O (2 Years Edition) | Thorasys Thoracic Medical Systems Inc | 2024-09-20 |
| 07540261021107 | tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU | Thorasys Thoracic Medical Systems Inc | 2024-09-20 |
| 07540261020797 | tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition | Thorasys Thoracic Medical Systems Inc | 2024-04-12 |
| 07540261010590 | TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L | Thorasys Thoracic Medical Systems Inc | 2021-11-03 |
| 07540261019234 | tremoflo C-100 Airwave Oscillometry - Support Arm | Thorasys Thoracic Medical Systems Inc | 2021-11-03 |
| 00860003953716 | PulmoScan | Cognita Labs, LLC | 2021-03-08 |
| 07540261025853 | tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition | Thorasys Thoracic Medical Systems Inc | 2018-07-18 |
| 07540261009860 | TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L | Thorasys Thoracic Medical Systems Inc | 2018-01-16 |
| 07540261013454 | tremoFlo US Software | Thorasys Thoracic Medical Systems Inc | 2018-01-16 |
| 07540261014215 | Clearflo PFT Filter in bag | Thorasys Thoracic Medical Systems Inc | 2018-01-16 |
| 07540261015243 | tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition | Thorasys Thoracic Medical Systems Inc | 2018-01-16 |
| 07540261016400 | Assembly of tremoflo US software and digital user manual CD | Thorasys Thoracic Medical Systems Inc | 2018-01-16 |
| 07540261013362 | tF C-100 Unit-ClearFlo PFT filter compatible | Thorasys Thoracic Medical Systems Inc | 2018-01-12 |