ER-7C CLINICAL PROBE MICROPHONE— 510(k) K861113

Name: FDA 510(k) clearance K861113
Creator: U.S. Food and Drug Administration
Published: 1986-04-23

Substantially Equivalent

Etymotic Research

FDA 510(k) clearance K861113 for ER-7C CLINICAL PROBE MICROPHONE, Substantially Equivalent on 1986-04-23. Applicant: Etymotic Research. Device class: 2.

Clearance details

Applicant: Etymotic Research
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1986-03-25
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

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