DeviceClearance

Product code PNV— Anesthesiology

PulmoScan

Classification name
Impedance Measuring Device Utilizing Oscillation Techniques
Device class
Class 2
Regulation
21 CFR 868.1840
Advisory panel
Anesthesiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“This device measures respiratory impedance.”

— U.S. Food and Drug Administration, device classification record for product code PNV under 21 CFR 868.1840, via openFDA

Market context for product code PNV

FDA has cleared 4 devices under product code PNV between 2016 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PNV

Recent clearances under product code PNV

Data sourced from openFDA. This site is unofficial and independent of the FDA.