PRIZM HEARING SYSTEM, MODEL POWER BTE— 510(k) K936007

Substantially Equivalent

Audioscience, Inc.

FDA 510(k) clearance K936007 for PRIZM HEARING SYSTEM, MODEL POWER BTE, Substantially Equivalent on 1994-03-04. Applicant: Audioscience, Inc..

Clearance details

Applicant: Audioscience, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1993-12-16
Decision date: 1994-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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