Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1840](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1840) → PNV — Impedance Measuring Device Utilizing Oscillation Techniques

# PNV · Impedance Measuring Device Utilizing Oscillation Techniques

_Anesthesiology · 21 CFR 868.1840 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV

## Overview

- **Product Code:** PNV
- **Device Name:** Impedance Measuring Device Utilizing Oscillation Techniques
- **Regulation:** [21 CFR 868.1840](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1840)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## 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](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV/K221024.md) | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | Jun 20, 2023 | SESE |
| [K191876](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV/K191876.md) | PulmoScan | Cognita Labs, LLC | Mar 18, 2020 | SESE |
| [K170185](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV/K170185.md) | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | Sep 12, 2017 | SESE |
| [K152585](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV/K152585.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PNV)

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