EARCHECK ACOUSTIC REFLECTOMETER— 510(k) K070312

Name: FDA 510(k) clearance K070312
Creator: U.S. Food and Drug Administration
Published: 2007-03-02

Substantially Equivalent

Innovia Medical, LLC

FDA 510(k) clearance K070312 for EARCHECK ACOUSTIC REFLECTOMETER, Substantially Equivalent on 2007-03-02. Applicant: Innovia Medical, LLC. Device class: 2.

Clearance details

Applicant: Innovia Medical, LLC
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2007-02-01
Decision date: 2007-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.