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510(k) Data Aggregation

    K Number
    K241338
    Device Name
    Peak Flow Meter
    Manufacturer
    Chongqing Moffy Innovation Technology Co.,Ltd.
    Date Cleared
    2024-12-31

    (232 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) 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 onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second 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
    Not Found
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    K Number
    K232588
    Device Name
    Aluna 2
    Manufacturer
    Knox Medical Diagnostics
    Date Cleared
    2024-11-25

    (458 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
    Device Description
    Aluna 2 consists of three main components: - A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth. - A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume. - An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.
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    K Number
    K230423
    Device Name
    Electronic Peak Flow Meter
    Manufacturer
    Taian Dalu Medical Instrument Co., Ltd.
    Date Cleared
    2024-02-23

    (371 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.
    Device Description
    The device is made up of two elements – the Electronic Peak Flow Meter and a Mobile Medical Application for smartphones that communicate via Bluetooth. The device is a portable device that can measure the Peak Expiratory Flow (PEF). The Electronic Peak Flow Meter consists of the main unit, turbine, and blowing mouthpiece. Electronic Peak Flow Meter software is embedded in the main control unit, which is used to control the whole system of operation. After compiling, the program is solidified into the hardware. The combination of software and hardware realizes the functions for electronic peak flow meter. When Electronic Peak Flow Meter connected to APP of communication devices (such as a mobile) through Bluetooth. The changes of the patient's PEF data within one week can be monitored by APP, so that it is more convenient to monitor the respiratory health status.
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    K Number
    K222810
    Device Name
    TD-7301 Peak Flow meter
    Manufacturer
    GOSTAR Co., Ltd.
    Date Cleared
    2023-12-19

    (459 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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?
    Product Code :

    BZH

    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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    K Number
    K200832
    Device Name
    Safey Peak Flow Meter
    Manufacturer
    Safey Medical Devices Pvt Ltd
    Date Cleared
    2020-07-30

    (122 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
    Device Description
    Safey Peak Flow Meter is an over-the-counter medical device to help respiratory patients keep track of their lung health. This device measures Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). Safey Peak Flow Meter is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Peak Flow Meter works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to PEF and FEV1. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.
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    K Number
    K193311
    Device Name
    Aluna
    Manufacturer
    Knox Medical Diagnostics, Inc.
    Date Cleared
    2020-03-25

    (117 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.
    Device Description
    Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
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    K Number
    K191239
    Device Name
    Smart Peak Flow Meter
    Manufacturer
    Guangzhou Homesun Medical Technology Co., Ltd
    Date Cleared
    2019-12-06

    (212 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    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 (FEV 1) 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.
    Device Description
    Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning. The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.
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    K Number
    K180487
    Device Name
    Peak.me
    Manufacturer
    Breathe me LTD
    Date Cleared
    2018-10-26

    (245 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peak.me is intended for monitoring FEVI (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.
    Device Description
    Peak.me is a hand-held Peak Flow Meter device that is intended for monitoring FEV1 (forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for pediatric to adult users. Peak.me is not recommended for children under 5 years of age. Peak.me consists of a mechanical unit, which physically attaches to the user's smartphone, and a software application which analyzes the measurements and serves as a disease management platform. The device uses the smartphone's internal upper microphone as a sensor and does not include any electrical parts. As the user exhales through the mechanical unit, it produces acoustic waves with a frequency proportional to the exhalation airflow rate, which then propagates to the smartphone's internal upper microphone. Peak.me software application analyzes the sound and displays the results. Furthermore, the application includes a review of past measurements. It enables manual input of symptoms and medication usage and provides guidance for correct usage and more.
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    K Number
    K181666
    Device Name
    Smart One
    Manufacturer
    MIR Medical International Research
    Date Cleared
    2018-08-01

    (37 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Product Code :

    BZH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEVI (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.
    Device Description
    Smart One is a pocket-sized system for monitoring the following respiratory parameters: PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). For each of these two parameters, the result is a number shown on the smartphone screen. PEF is also associated with a three zone monitoring system that, according to the result, may be green, yellow or red. Smart One is made up of two elements - the device and a Mobile Medical Application for smartphones (or tablets) that communicate via Bluetooth Smart 4.0.
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