Cleared Traditional

ALGO Pro Newborn Hearing Screener (ALGO Pro)

K233649 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Ear, Nose, Throat
Mar 2024
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K233649 is an FDA 510(k) clearance for the ALGO Pro Newborn Hearing Screener (ALGO Pro), a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on March 8, 2024, 115 days after receiving the submission on November 14, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K233649 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date March 08, 2024
Days to Decision 115 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900