BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SAFETYMATE TALKING FIRST AID

    K Number: K110625 · Decision Jun 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    SAFETYMATE TALKING FIRST AID
    K Number
    K110625
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safetymate, Inc.
    Date Received
    March 4, 2011
    Decision Date
    June 17, 2011
    Product Code
    OVR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OVR Kit, First Aid, Talking