MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT— 510(k) K962228

Substantially Equivalent

Ototech Intl., Inc.

FDA 510(k) clearance K962228 for MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT, Substantially Equivalent on 1996-08-28. Applicant: Ototech Intl., Inc..

Clearance details

Applicant: Ototech Intl., Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1996-06-10
Decision date: 1996-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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