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

    Phoenix Digital Thermometer

    K Number: K201032 · Decision Oct 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    557

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    Basic Information

    Device Name
    Phoenix Digital Thermometer
    K Number
    K201032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
    Date Received
    April 20, 2020
    Decision Date
    October 29, 2021
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

    K Number Device Name
    K231123 Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)