BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BAGRIGHT RESUSCITATOR

    K Number: K954296 · Decision Dec 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    13
    Review Days
    97

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    Basic Information

    Device Name
    BAGRIGHT RESUSCITATOR
    K Number
    K954296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Marketing Concepts
    Date Received
    September 14, 1995
    Decision Date
    December 20, 1995
    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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    Other Clearances by Medical Marketing Concepts

    K Number Device Name
    K982215 MANUAL RESUSCITATOR WITH ACE
    K961867 PEEP VALVE
    K961330 BAGRIGHT INFANT RESUSCITATOR
    K961329 BAGRIGHT CHILD RESUSCITATOR
    K961369 BAGRIGHT RESPOSABLE RESUSCITATOR
    K961332 BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
    K961331 BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
    K961868 RESPOSABLE CHILD RESUSCITATOR
    K961882 RESPOSABLE INFANT RESUSCITATOR
    K953546 MANUAL PULMONARY RESUSICITATOR
    Search all 13 clearances from Medical Marketing Concepts →