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510(k) Data Aggregation

    K Number
    K172870
    Device Name
    Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
    Manufacturer
    Hangzhou Hua'an medical&health instruments Co.,Ltd
    Date Cleared
    2018-02-13

    (146 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hangzhou Hua'an medical&health instruments Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.
    Device Description
    Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
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    K Number
    K172861
    Device Name
    Digital thermometer(with disposable thermometer cover)
    Manufacturer
    Hangzhou Hua'an medical&health instruments Co.,Ltd
    Date Cleared
    2017-12-19

    (90 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hangzhou Hua'an medical&health instruments Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
    Device Description
    electronic clinical thermometer
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    K Number
    K160999
    Device Name
    Infra-red forehead thermometer
    Manufacturer
    HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD
    Date Cleared
    2016-08-01

    (112 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models FT-100A FT-100D FT-100E are electronic clinical thermometer intended to measure human body temperature in people of all ages, its operation is based on measuring the natural thermal radiation emanating from the forehead.
    Device Description
    Not Found
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    K Number
    K122912
    Device Name
    DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2012-11-07

    (47 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
    Device Description
    Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D
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    K Number
    K092447
    Device Name
    DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2010-01-07

    (150 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models DT Series (barring model DT-201A and DT-211A) are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages. The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
    Device Description
    Not Found
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    K Number
    K092514
    Device Name
    UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2009-12-04

    (109 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
    Device Description
    Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series
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    K Number
    K041693
    Device Name
    WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2004-12-02

    (163 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
    Device Description
    Not Found
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    K Number
    K041692
    Device Name
    INFRARED EAR THERMOMETER, ET-100 SERIES
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2004-09-13

    (83 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.
    Device Description
    Infrared Ear Thermometer Model ET-100 Series
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    K Number
    K041694
    Device Name
    DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2004-09-13

    (83 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models DT-02 and DT-101 are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages. The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
    Device Description
    Digital Flexible Thermometer Model DT-101 Basal Digital Thermometer Model DT-02 Digital Pacifier Thermometer Model NT-01
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    K Number
    K030361
    Device Name
    JASUN, MODELS DT-01F AND DT-11F
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2003-02-21

    (18 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices models DT-01Fand DT-11F are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
    Device Description
    Digital Thermometer Model DT-01F & DT-11F
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