HEARING AID, UNITRON BTE MODEL UM60-AGC0— 510(k) K884288

Name: FDA 510(k) clearance K884288
Creator: U.S. Food and Drug Administration
Published: 1989-01-03

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K884288 for HEARING AID, UNITRON BTE MODEL UM60-AGC0, Substantially Equivalent on 1989-01-03. 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: 1988-10-12
Decision date: 1989-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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