510(k) K964639— TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II

Substantially Equivalent

Telex Communications, Inc.

Clearance details

Applicant: Telex Communications, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1996-11-19
Decision date: 1997-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.