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

    Nautilus BrainPulse 1000

    K Number: DEN140040 · Decision Aug 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    587

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    Basic Information

    Device Name
    Nautilus BrainPulse 1000
    K Number
    DEN140040
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1630
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Jan Medical, Inc.
    Date Received
    December 23, 2014
    Decision Date
    August 1, 2016
    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.

    BrainPulse 1100

    FDA 510(k)
    FDA Class 2 ·Neurology
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    Other Clearances by Jan Medical, Inc.

    K Number Device Name
    K170926 BrainPulse 1100