MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL— 510(k) K924450

Name: FDA 510(k) clearance K924450
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

Mediphonix, Inc.

FDA 510(k) clearance K924450 for MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL, Substantially Equivalent on 1992-10-05. Applicant: Mediphonix, Inc.. Device class: 1.

Clearance details

Applicant: Mediphonix, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1992-08-31
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, GA, US

Download summary PDF View on FDA.gov ↗

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