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

    BrainPulse 1100

    K Number: K170926 · Decision Apr 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    BrainPulse 1100
    K Number
    K170926
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1630
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jan Medical, Inc.
    Date Received
    March 29, 2017
    Decision Date
    April 28, 2017
    Product Code
    POP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    POP Cranial Motion Measurement Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (POP), ordered by most recent decision date.

    Nautilus BrainPulse 1000

    FDA 510(k)
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    Other Clearances by Jan Medical, Inc.

    K Number Device Name
    DEN140040 Nautilus BrainPulse 1000