BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MODIFICATION TO:APEX MEDICAL IF-4100

    K Number: K013813 · Decision Dec 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    30
    Review Days
    28

    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
    MODIFICATION TO:APEX MEDICAL IF-4100
    K Number
    K013813
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apex Medical Corp.
    Date Received
    November 16, 2001
    Decision Date
    December 14, 2001
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXY Electrode, Cutaneous

    Similar 510(k) Clearances

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

    BioWave BioWraps

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MR Conditional Cup Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tutamen Self Adhesive Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceribell Brain Monitor Headband

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

    Other Clearances by Apex Medical Corp.

    K Number Device Name
    K213577 VenAir, Sequential Compression System
    K193206 WiZARD 510 Nasal Mask
    K182394 WiZARD 310/320 Series CPAP Mask
    K150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
    K141522 APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
    K121642 WIZARD 230 NASAL PILOW MASK
    K112079 APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
    K120035 APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
    K103174 APEX MEDICAL WIZARD SERIES CPAP MASK
    K103535 VACPLUS SUCTION UNIT
    Search all 30 clearances from Apex Medical Corp. →