BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

    Smile-100 System

    K Number: K212965 · Decision Mar 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    Smile-100 System
    K Number
    K212965
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Niramai Health Analytix Private Limited
    Date Received
    September 16, 2021
    Decision Date
    March 10, 2022
    Product Code
    LHQ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHQ System, Telethermographic (Adjunctive Use)

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