Product Code: PNV
FDA class 2
21 CFR 868.1840
Impedance Measuring Device Utilizing Oscillation Techniques
Anesthesiology
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.
510(k)s
4
FEI Numbers
2
Registration Numbers
2
Unique Applicants
4
Years Active
7
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
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
This device measures respiratory impedance.
510(k) Clearance History
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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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.