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

    SONA PILLOW

    K Number: K040161 · Decision Apr 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    98

    Basic Information

    Device Name
    SONA PILLOW
    K Number
    K040161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SLEEP DEVICES, INC.
    Date Received
    January 23, 2004
    Decision Date
    April 30, 2004
    Product Code
    MYB
    Advisory Committee
    Dental
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MYB Pillow, Cervical (For Mild Sleep Apnea)

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