HEARING AID, UNITRON UE12-PPL— 510(k) K843246

Name: FDA 510(k) clearance K843246
Creator: U.S. Food and Drug Administration
Published: 1985-01-23

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K843246 for HEARING AID, UNITRON UE12-PPL, Substantially Equivalent on 1985-01-23. Applicant: Unitron Industries, Inc.. Device class: 1.

Clearance details

Applicant: Unitron Industries, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1984-08-20
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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