EURION LOTOS PP HEARING AID— 510(k) K923226

Name: FDA 510(k) clearance K923226
Creator: U.S. Food and Drug Administration
Published: 1992-07-30

Substantially Equivalent

Eurion Hearing Instruments

FDA 510(k) clearance K923226 for EURION LOTOS PP HEARING AID, Substantially Equivalent on 1992-07-30. Applicant: Eurion Hearing Instruments. Device class: 1.

Clearance details

Applicant: Eurion Hearing Instruments
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1992-07-01
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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