AUDIOSCAN VERIFIT, MODEL VF-1— 510(k) K012306

Name: FDA 510(k) clearance K012306
Creator: U.S. Food and Drug Administration
Published: 2001-09-21

Substantially Equivalent

Etymonic Design, Inc.

FDA 510(k) clearance K012306 for AUDIOSCAN VERIFIT, MODEL VF-1, Substantially Equivalent on 2001-09-21. 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: 2001-07-23
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dorchester, Ontario, CA

Download summary PDF View on FDA.gov ↗

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