Impedance Measuring Device Utilizing Oscillation Techniques
The Impedance Measuring Device Utilizing Oscillation Techniques (product code PNV) is a Class 2 anesthesiology device that measures respiratory impedance using oscillation techniques, regulated under 868.1840. It requires 510(k) clearance and falls within the anesthesiology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PNV
- Device Class
- FDA class 2
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
This device measures respiratory impedance.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry System | Jun 20, 2023 | Substantially Equivalent | Thorasys Thoracic Medical Systems, Inc. |
| K191876 | PulmoScan | Mar 18, 2020 | Substantially Equivalent | Cognita Labs, LLC |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Sep 12, 2017 | Substantially Equivalent | Thorasys Thoracic Medical Systems, Inc. |
| K152585 | Resmon PRO FULL | Jun 24, 2016 | Substantially Equivalent | Medical Graphics Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.