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510(k) Data Aggregation

    K Number
    K242455
    Device Name
    AViTA Pulse Oximeter (SP62B)
    Manufacturer
    AViTA Corporation
    Date Cleared
    2025-02-19

    (184 days)

    Product Code
    DQA, DOA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    AViTA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition. The device is prescription only.
    Device Description
    The subject device AVITA Pulse Oximeter with Bluetooth is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.
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    K Number
    K241852
    Device Name
    Nasal Aspirator (NS 13)
    Manufacturer
    AViTA Corporation
    Date Cleared
    2024-12-31

    (187 days)

    Product Code
    BTA, KMA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    AViTA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment. The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
    Device Description
    This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.
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    K Number
    K242193
    Device Name
    Arm Type Blood Pressure Monitor (BPM82)
    Manufacturer
    AViTA Corporation
    Date Cleared
    2024-10-22

    (88 days)

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

    AViTA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product automatically measures human being's Systolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 150 mm to 520 mm (Approx.6 ~ 21 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.
    Device Description
    The AVITA Arm Type Blood Pressure Monitor (Model BPM82) consists of a main unit with an LCD display and four buttons, along with a cuff component. The device is designed for accurate and convenient monitoring of an individual's blood pressure and pulse rate through the application of oscillometric methodology. Specifically engineered for use on the upper arm, this over-the-counter device is tailored to adults with upper arm circumferences ranging from 150 mm to 520 mm (Approx. 6~ 21 inches) for in-home use.
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    K Number
    K223399
    Device Name
    AViTA Pulse Oximeter
    Manufacturer
    AViTA Corporation
    Date Cleared
    2024-05-20

    (558 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    AViTA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.
    Device Description
    The AViTA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.
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    K Number
    K200346
    Device Name
    Wrist Type Blood Pressure Monitor
    Manufacturer
    Avita Corporation
    Date Cleared
    2020-12-17

    (310 days)

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

    Avita Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BPM16B automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use
    Device Description
    Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate.
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    K Number
    K180155
    Device Name
    Arm Type Blood Pressure Monitor
    Manufacturer
    Avita Corporation
    Date Cleared
    2018-08-03

    (196 days)

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

    Avita Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BPM64R automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.
    Device Description
    Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate. The Blood Pressure Monitor, BPM64R uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
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    K Number
    K172427
    Device Name
    AViTA Radar Thermo NT16 Series IR Thermometer
    Manufacturer
    Avita Corporation
    Date Cleared
    2018-04-19

    (252 days)

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

    Avita Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AViTA Radar Thermo NT16 Series IR Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature from the forehead in people of all ages.
    Device Description
    AViTA Radar Thermo NT16 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT16 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from the forehead of human body.
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    K Number
    K112825
    Device Name
    AVITA ARM TYPE BLOOD PRESSURE MONITOR
    Manufacturer
    AVITA CORPORATION
    Date Cleared
    2012-01-18

    (112 days)

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

    AVITA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.
    Device Description
    AViTA BPM6x Series Arm Type Blood Pressure Monitor
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    K Number
    K110559
    Device Name
    AVITA INFRARED THEROMETER WITH BLUETOOTH
    Manufacturer
    AVITA CORPORATION
    Date Cleared
    2012-01-06

    (312 days)

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

    AVITA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    AVITA Infrared Thermometer with Bluetooth Model no.: TS28B
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    K Number
    K102554
    Device Name
    AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
    Manufacturer
    AVITA CORPORATION
    Date Cleared
    2011-03-03

    (177 days)

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

    AVITA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    Not Found
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