Lumen 155-SF— 510(k) K223911

Substantially Equivalent

Intricon Corporation

FDA 510(k) clearance K223911 for Lumen 155-SF, Substantially Equivalent on 2023-10-17. Applicant: Intricon Corporation. Device class: 2.

Clearance details

Applicant
Intricon Corporation
Product code
Code QDD
Device class
Class 2
Regulation
21 CFR 874.3325
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arden Hills, MN, US
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