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

    Safey Peak Flow Meter

    K Number: K200832 · Decision Jul 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    122

    Basic Information

    Device Name
    Safey Peak Flow Meter
    K Number
    K200832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safey Medical Devices Pvt Ltd
    Date Received
    March 30, 2020
    Decision Date
    July 30, 2020
    Product Code
    BZH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZH Meter, Peak Flow, Spirometry

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    Other Clearances by Safey Medical Devices Pvt Ltd

    K Number Device Name
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