BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Eva Scalp Cooling System

    K Number: K252289 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    125

    Basic Information

    Device Name
    Eva Scalp Cooling System
    K Number
    K252289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stemtech Medical Devices Private Limited
    Date Received
    July 23, 2025
    Decision Date
    November 25, 2025
    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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