ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM— 510(k) K901503

Name: FDA 510(k) clearance K901503
Creator: U.S. Food and Drug Administration
Published: 1990-06-28

Substantially Equivalent

Stanton Magnetics, Inc.

FDA 510(k) clearance K901503 for ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM, Substantially Equivalent on 1990-06-28. Applicant: Stanton Magnetics, Inc.. Device class: 1.

Clearance details

Applicant: Stanton Magnetics, Inc.
Product code: Code ESE
Device class: Class 1
Regulation: 21 CFR 874.3375
Advisory panel: Ear, Nose, Throat
Date received: 1990-03-30
Decision date: 1990-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainview, NY, US

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