ALGO Pro Newborn Hearing Screener (ALGO Pro)— 510(k) K233649

Name: FDA 510(k) clearance K233649
Creator: U.S. Food and Drug Administration
Published: 2024-03-08

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K233649 for ALGO Pro Newborn Hearing Screener (ALGO Pro), Substantially Equivalent on 2024-03-08. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2023-11-14
Decision date: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWJ

view all

K242954 — Integrity V500 (Integrity, Integrity with VEMP)2024-12-19
K220139 — QScreen2022-08-03
K211147 — ALGO 7i2021-10-14
K193033 — GSI Audera Pro2020-04-24
K163326 — SmartEP2017-09-29

More clearances from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

view all

K242930 — Natus BrainWatch System2024-11-19
K203500 — RetCam Envision2021-04-13
K200878 — Natus NeuroWorks2020-05-18
K173936 — Natus Photic Stimulator2018-06-15
K180290 — Natus Brain Monitor Amplifier2018-06-14

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