OMNI— 510(k) K811158

Substantially Equivalent

Omni Hearing Systems

FDA 510(k) clearance K811158 for OMNI, Substantially Equivalent on 1981-05-27. Applicant: Omni Hearing Systems.

Clearance details

Applicant: Omni Hearing Systems
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1981-04-28
Decision date: 1981-05-27
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.