PNV · Impedance Measuring Device Utilizing Oscillation Techniques
Anesthesiology · 21 CFR 868.1840 · Class 2
Overview
| Product Code | PNV |
|---|---|
| Device Name | Impedance Measuring Device Utilizing Oscillation Techniques |
| Regulation | 21 CFR 868.1840 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | Jun 20, 2023 | SESE |
| K191876 | PulmoScan | Cognita Labs, LLC | Mar 18, 2020 | SESE |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | Sep 12, 2017 | SESE |
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | Jun 24, 2016 | SESE |
Top Applicants
- Thorasys Thoracic Medical Systems, Inc. — 2 clearances
- Cognita Labs, LLC — 1 clearance
- Medical Graphics Corp. — 1 clearance
