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

    SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

    K Number: K042556 · Decision Mar 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    1
    Review Days
    172

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    Basic Information

    Device Name
    SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
    K Number
    K042556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enter Medical Corporation
    Date Received
    September 20, 2004
    Decision Date
    March 11, 2005
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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