HEARING AID (ALL IN THE EAR)— 510(k) K861492

Substantially Equivalent

Crystal Tone Hearing Instruments

FDA 510(k) clearance K861492 for HEARING AID (ALL IN THE EAR), Substantially Equivalent on 1986-05-02. Applicant: Crystal Tone Hearing Instruments. Device class: 1.

Clearance details

Applicant
Crystal Tone Hearing Instruments
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
Des Moines, IA, US
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