AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500— 510(k) K884046

Name: FDA 510(k) clearance K884046
Creator: U.S. Food and Drug Administration
Published: 1989-02-13

Substantially Equivalent

Etymonic Design, Inc.

FDA 510(k) clearance K884046 for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500, Substantially Equivalent on 1989-02-13. Applicant: Etymonic Design, Inc.. Device class: 2.

Clearance details

Applicant: Etymonic Design, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1988-09-26
Decision date: 1989-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dorchester, Ontario, CA

Download summary PDF View on FDA.gov ↗

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