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

    DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315

    K Number: K860583 · Decision Feb 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    18
    Applicant Total
    13
    Review Days
    3

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    Basic Information

    Device Name
    DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
    K Number
    K860583
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Dale Medical Products, Inc.
    Date Received
    February 18, 1986
    Decision Date
    February 21, 1986
    Product Code
    JAY
    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
    JAY Support, Breathing Tube

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