510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PNVClass II

Impedance Measuring Device Utilizing Oscillation Techniques

21 CFR 868.1840 / Anesthesiology
FDA source (opens on fda.gov)

PNV is the FDA product code for Impedance Measuring Device Utilizing Oscillation Techniques, a class II device type, regulated under 21 CFR 868.1840. FDA's definition for this code reads: "This device measures respiratory impedance". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PNV
Device name
Impedance Measuring Device Utilizing Oscillation Techniques
FDA definition
This device measures respiratory impedance.
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code PNV

By decision year
4 clearances under product code PNV with a decision year between 2016 and 2023, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PNV by decision year
YearClearances
20161
20171
20201
20231

Applicants with the most clearances

Product code PNV
Applicants holding the most 510(k) clearances under product code PNV
ApplicantClearances
Thorasys Thoracic Medical Systems Inc.2
Cognita Labs LLC1
Medical Graphics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code