BEHIND-THE-EAR HEARING AID MODEL 48 PP PC— 510(k) K892336

Substantially Equivalent

Qualitone

FDA 510(k) clearance K892336 for BEHIND-THE-EAR HEARING AID MODEL 48 PP PC, Substantially Equivalent on 1989-05-19. Applicant: Qualitone. Device class: 1.

Clearance details

Applicant
Qualitone
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
Minneapolis, MN, US
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