BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇸🇪 Sweden

    Dignitana AB DigniCap System

    K Number: DEN150010 · Decision Dec 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    277

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    Basic Information

    Device Name
    Dignitana AB DigniCap System
    K Number
    DEN150010
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Dignitana AB
    Date Received
    March 6, 2015
    Decision Date
    December 8, 2015
    Product Code
    PMC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PMC Scalp Cooling System

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    Other Clearances by Dignitana AB

    K Number Device Name
    K170871 DigniCap Scalp Cooling System