CUSTOM, IN-THE-EAR HEARING AID— 510(k) K821390

Substantially Equivalent

Ear-Tronics, Inc.

FDA 510(k) clearance K821390 for CUSTOM, IN-THE-EAR HEARING AID, Substantially Equivalent on 1982-06-07. Applicant: Ear-Tronics, Inc..

Clearance details

Applicant: Ear-Tronics, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1982-05-11
Decision date: 1982-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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