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
QEBClass II

Ventilatory Electrical Impedance Tomograph

21 CFR 868.1505 / Anesthesiology
FDA source (opens on fda.gov)

QEB is the FDA product code for Ventilatory Electrical Impedance Tomograph, a class II device type, regulated under 21 CFR 868.1505. FDA's definition for this code reads: "A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEB
Device name
Ventilatory Electrical Impedance Tomograph
FDA definition
A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax.
Regulation
21 CFR 868.1505
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
6
Ingested recalls
0

Clearances, product code QEB

By decision year
6 clearances under product code QEB with a decision year between 2018 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QEB by decision year
YearClearances
20181
20221
20232
20252

Applicants with the most clearances

Product code QEB
Applicants holding the most 510(k) clearances under product code QEB
ApplicantClearances
Timpel S.A.4
Bilab1
Sentec AG1

Companies listing this code with FDA

Companies whose registered establishments list this code