BEHIND-THE-EAR HEARING AID MODEL 48 AGCI— 510(k) K892338

Substantially Equivalent

Qualitone

FDA 510(k) clearance K892338 for BEHIND-THE-EAR HEARING AID MODEL 48 AGCI, Substantially Equivalent on 1989-08-03. Applicant: Qualitone.

Clearance details

Applicant: Qualitone
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1989-04-05
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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