SMART-EP— 510(k) K904926

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K904926 for SMART-EP, Substantially Equivalent on 1991-08-02. Applicant: Intelligent Hearing Systems. Device class: 2.

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 1990-10-31
Decision date: 1991-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWJ

K242954 — Integrity V500 (Integrity, Integrity with VEMP)2024-12-19
K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)2024-03-08
K220139 — QScreen2022-08-03
K211147 — ALGO 7i2021-10-14
K193033 — GSI Audera Pro2020-04-24

More clearances from Intelligent Hearing Systems

K163326 — SmartEP2017-09-29
K090579 — SMARTSCREENER-PLUS22009-07-07
K073384 — SMART COUPLER, MODEL M0154012008-02-28
K070608 — SMARTEP, MODEL M0100002007-07-18
K063402 — WICK ELECTRODE, MODEL M0192602006-12-11

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