HEARING AID, UNITRON MODEL VISTA 1000— 510(k) K883513

Name: FDA 510(k) clearance K883513
Creator: U.S. Food and Drug Administration
Published: 1988-09-01

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K883513 for HEARING AID, UNITRON MODEL VISTA 1000, Substantially Equivalent on 1988-09-01. 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: 1988-08-17
Decision date: 1988-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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