BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Keeogo Dermoskeleton System

    K Number: K201539 · Decision Sep 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    Keeogo Dermoskeleton System
    K Number
    K201539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3480
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-Temia, Inc.
    Date Received
    June 9, 2020
    Decision Date
    September 9, 2020
    Product Code
    PHL
    Advisory Committee
    Physical Medicine
    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
    PHL Powered Exoskeleton

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