OTOMETER PORTABLE SCREENING AUDIOMETER— 510(k) K883169

Name: FDA 510(k) clearance K883169
Creator: U.S. Food and Drug Administration
Published: 1988-12-07

Substantially Equivalent

Otometer, Inc.

FDA 510(k) clearance K883169 for OTOMETER PORTABLE SCREENING AUDIOMETER, Substantially Equivalent on 1988-12-07. Applicant: Otometer, Inc.. Device class: 2.

Clearance details

Applicant: Otometer, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1988-07-27
Decision date: 1988-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EWO

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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

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.