ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,— 510(k) K141446

Name: FDA 510(k) clearance K141446
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Natus Medical Incorporated

FDA 510(k) clearance K141446 for ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,, Substantially Equivalent on 2014-08-22. Applicant: Natus Medical Incorporated. Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2014-06-02
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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