RASTRONICS CCI 10/3 HEARING AID ANALYSIS— 510(k) K902252

Name: FDA 510(k) clearance K902252
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

Rastronics USA, Inc.

FDA 510(k) clearance K902252 for RASTRONICS CCI 10/3 HEARING AID ANALYSIS, Substantially Equivalent on 1990-09-12. Applicant: Rastronics USA, Inc.. Device class: 2.

Clearance details

Applicant: Rastronics USA, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1990-05-21
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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