CUSTOM PERSONAL EAR - CPE— 510(k) K911497

Substantially Equivalent

Qualitone

FDA 510(k) clearance K911497 for CUSTOM PERSONAL EAR - CPE, Substantially Equivalent on 1991-04-19. Applicant: Qualitone.

Clearance details

Applicant: Qualitone
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1991-04-01
Decision date: 1991-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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