BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ALGO Pro Newborn Hearing Screener (ALGO Pro)

    K Number: K233649 · Decision Mar 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    12
    Review Days
    115

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ALGO Pro Newborn Hearing Screener (ALGO Pro)
    K Number
    K233649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
    Date Received
    November 14, 2023
    Decision Date
    March 8, 2024
    Product Code
    GWJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWJ Stimulator, Auditory, Evoked Response

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWJ), ordered by most recent decision date.

    Integrity V500 (Integrity, Integrity with VEMP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    QScreen

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALGO 7i

    FDA 510(k)
    FDA Class 2 ·Neurology

    GSI Audera Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    SmartEP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Eclipse with VEMP

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

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

    K Number Device Name
    K242930 Natus BrainWatch System
    K203500 RetCam Envision
    K200878 Natus NeuroWorks
    K173936 Natus Photic Stimulator
    K180290 Natus Brain Monitor Amplifier
    K180421 Natus NeuroWorks
    K173690 Grass TWin
    K172711 Comet-PLUS
    K163163 XLTEK EMU40EX EEG Headbox
    K162595 Trex_HD
    Search all 12 clearances from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) →