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QVNClass II

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

21 CFR 874.3410 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QVN is the FDA product code for Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus, a class II device type, regulated under 21 CFR 874.3410. FDA's definition for this code reads: "A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QVN
Device name
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
FDA definition
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
Regulation
21 CFR 874.3410
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QVN

By decision year
1 clearance under product code QVN with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVN by decision year
YearClearances
20231

Applicants with the most clearances

Product code QVN
Applicants holding the most 510(k) clearances under product code QVN
ApplicantClearances
Neuromod Devices Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code