FDA Product Code PNV: Impedance Measuring Device Utilizing Oscillation Techniques
This Device Measures Respiratory Impedance.
Leading manufacturers include 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
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.
PNV devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →