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510(k) Data Aggregation

    K Number
    K233192
    Device Name
    Wireless Smart Thermometer
    Date Cleared
    2024-04-05

    (190 days)

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

    Famidoc Technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatic patient population (not suitable for neonates).
    Device Description
    Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) utilizes a modular design method and consists of six main modules: - Buzzer module: Control the product buzzer to produce audible notifications; - Display module: Display driver content through notifications, and combine to produce various display interfaces; - Battery voltage management module: Detect the battery power of the product and output the battery power level; - Temperature measurement module: After collecting the electrical signal of the external temperature sensor through AD, it is restored to the temperature value through various algorithms - Button module: This module is used to identify whether the product button is active; - Wireless function module: Transfer the measurement data to the mobile device.
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    K Number
    K222887
    Device Name
    Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
    Date Cleared
    2023-04-10

    (199 days)

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

    Famidoc Technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).
    Device Description
    Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、 FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) includes utilize modular design method. It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, , wireless function module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.
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    K Number
    K191673
    Device Name
    Upper Arm Blood Pressure Monitor
    Date Cleared
    2019-11-27

    (156 days)

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

    Famidoc Technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.
    Device Description
    FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.
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