PNV · Class II · 21 CFR 868.1840

FDA Product Code PNV: Impedance Measuring Device Utilizing Oscillation Techniques

This Device Measures Respiratory Impedance.

Leading manufacturers include Cognita Labs, LLC and Thorasys Thoracic Medical Systems, Inc..

4
Total
4
Cleared
302d
Avg days
2016
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Impedance Measuring Device Utilizing Oscillation Techniques Devices (Product Code PNV)

4 devices
1–4 of 4
Cleared Jun 20, 2023
tremoflo C2 Airwave Oscillometry System
K221024
Thorasys Thoracic Medical Systems, Inc.
Anesthesiology · 440d
Cleared Mar 18, 2020
PulmoScan
K191876
Cognita Labs, LLC
Anesthesiology · 247d

About Product Code PNV - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code PNV since 2016, with 4 receiving FDA clearance (average review time: 302 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.