ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)— 510(k) K980533

Name: FDA 510(k) clearance K980533
Creator: U.S. Food and Drug Administration
Published: 1998-03-23

Substantially Equivalent

Etymotic Research

FDA 510(k) clearance K980533 for ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34), Substantially Equivalent on 1998-03-23. Applicant: Etymotic Research. Device class: 2.

Clearance details

Applicant: Etymotic Research
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1998-02-11
Decision date: 1998-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EWO

view all

K234095 — OtoNova/OtoNova Pro2024-06-21
K240430 — Otoport Pro2024-03-15
K231545 — hearOAE2023-10-27
K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K191372 — Lyra2019-07-15

More clearances from Etymotic Research

view all

K011114 — ETYMOTIC RESEARCH ER-10D OAE PROBE2001-07-03
K010165 — ERO SCAN OAE TEST SYSTEM2001-03-12
K930553 — CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT1993-09-29
K930003 — TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES1993-06-18
K873298 — ELEC-TIP1987-11-24

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.