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    K Number
    K203196
    Device Name
    Peak flow meter
    Manufacturer
    Shanghai Sonmol Medical Equipment Co., Ltd.
    Date Cleared
    2021-05-26

    (210 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Sonmol Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.
    Device Description
    The Peak flow meter is composed of Main Unit and Mouthpiece. Mouthpiece: Mouth blowing. Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit. The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.
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