UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE— 510(k) K974340

Name: FDA 510(k) clearance K974340
Creator: U.S. Food and Drug Administration
Published: 1997-12-12

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K974340 for UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE, Substantially Equivalent on 1997-12-12. 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: 1997-11-18
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

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