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

    SHINMED MODE SW-988 UNTRASONIC NEBULIZER

    K Number: K031370 · Decision Sep 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    4
    Review Days
    490

    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
    SHINMED MODE SW-988 UNTRASONIC NEBULIZER
    K Number
    K031370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shining World Health Care Co., Ltd.
    Date Received
    April 30, 2003
    Decision Date
    September 1, 2004
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

    Similar 510(k) Clearances

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

    FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    eRapid with eTrack System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mesh Nebulizer (H6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portable mesh nebulizer (JM821)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HeroTracker Sense

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

    Other Clearances by Shining World Health Care Co., Ltd.

    K Number Device Name
    K213317 ShinEvac Smoke Evacuation Pencil
    K033027 SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
    K980024 SHINMED MODEL SW-966 ULTRASONIC NEBULIZER