ASL CUSTOM IN-THE-EAR HEARING AID #L— 510(k) K801023

Substantially Equivalent

American Sound Labs

FDA 510(k) clearance K801023 for ASL CUSTOM IN-THE-EAR HEARING AID #L, Substantially Equivalent on 1980-05-28. Applicant: American Sound Labs. Device class: 1.

Clearance details

Applicant
American Sound Labs
Product code
Code ESD
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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