SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT— 510(k) K961447

Name: FDA 510(k) clearance K961447
Creator: U.S. Food and Drug Administration
Published: 1996-05-29

Substantially Equivalent

Bio-Logic Systems Corp.

FDA 510(k) clearance K961447 for SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT, Substantially Equivalent on 1996-05-29. Applicant: Bio-Logic Systems Corp.. Device class: 2.

Clearance details

Applicant: Bio-Logic Systems Corp.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1996-04-16
Decision date: 1996-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mudelein, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bio-Logic Systems Corp.

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K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM2012-11-01
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K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM2008-02-05
K061744 — COCHLEA-SCAN / COCHLEA-SCAN PLUS2006-09-15
K052066 — CEEGRAPH/SLEEPSCAN NETLINK TRAVELER2005-08-26

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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