DEMLAR SYS I COMPUTER BASED AUDIOMETER— 510(k) K841167

Name: FDA 510(k) clearance K841167
Creator: U.S. Food and Drug Administration
Published: 1984-06-27

Substantially Equivalent

Demlar Medical, Inc.

FDA 510(k) clearance K841167 for DEMLAR SYS I COMPUTER BASED AUDIOMETER, Substantially Equivalent on 1984-06-27. Applicant: Demlar Medical, Inc.. Device class: 2.

Clearance details

Applicant: Demlar Medical, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1984-03-19
Decision date: 1984-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Demlar Medical, Inc.

view all

K803072 — HIGH FREQUENCY AUDIOMETER DELMAR #20-K1980-12-30

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.