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510(k) Data Aggregation

    K Number
    K211779
    Device Name
    ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
    Date Cleared
    2022-05-26

    (351 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chip Ideas Electronics S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eKuore Stethoscope Touch is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
    Device Description
    eKuore Stethoscope Touch is formed by eKuore Stethoscope Touch device, eKuore Medical Devices App and eKuore Touch Android Engine. The eKuore Stethoscope Touch device introduces three different models: - . ES001 is the basic version of the electronic stethoscope for general purposes. - . ES002 is an electronic stethoscope designed for people with hearing problems and enable hearing aids connection. - ES003 is an electronic stethoscope that can connect to third-party software ● using an Android Library. The primary purpose of the eKuore Stethoscope Touch device is to detect and amplify heart, lung, arteries, veins, and internal sounds using selective frequency organ ranges. The design of eKuore Stethoscope Touch lets the user change the chestpiece attached between different sizes depending on the patient to be auscultated. The primary purpose of the eKuore Medical Devices App is to get the acoustic signals from the eKuore Stethoscope Touch device. Once the device is turned on, the smartphone/tablet could detect a Bluetooth device. After the connection, the eKuore Medical Devices App displays the acoustic signal as a phonogram in real-time, on the monitor screen, there is a record button. When it is pressed, the recording start, a record maximum duration of 30 seconds is defined. To stop the record, the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet. Each recording is stored named with the date and time of the moment of the record. eKuore Medical Devices App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Medical Devices App lets the user share the records. eKuore Touch Android Engine enable third party companies to connect eKuore Stethoscope Touch model ES003 to obtain the audio from the device and use it in their own software. Audio is transmitted without modifications or processing.
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    K Number
    K212013
    Device Name
    eKuore Pro 4T - REF EP0098
    Date Cleared
    2021-11-10

    (135 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chip Ideas Electronics S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
    Device Description
    eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine. - . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine. - eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device. The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated. eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities: - Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN. - Get and set additional information about the connected device: ● - o The battery level of the device - The firmware version of the device o - The serial number of the device o - The volume level of the device o - The filter currently being used in the auscultation O - The hardware version of the device o - Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
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    K Number
    K201742
    Device Name
    eKuore One Wireless Electronic Interface for stethoscope
    Date Cleared
    2020-11-24

    (152 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chip Ideas Electronics S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
    Device Description
    The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery. The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application. The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that. The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.
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    K Number
    K203007
    Device Name
    eKuore Pro Series
    Date Cleared
    2020-10-30

    (29 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chip Ideas Electronics S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eKuore Pro Series is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro Series is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
    Device Description
    eKuore Pro Series is formed by eKuore Pro Series device and eKuore Pro App. The eKuore Pro Series device introduce three different models: - . eKuore Pro, the basic version of the stethoscope. - eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App. The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated. The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification. After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. To stop the record the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet, each recording is stored named with the date and time of the moment of the record. eKuore Pro App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Pro App lets the user share the records. Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.
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    K Number
    K181882
    Device Name
    eKuore One electronic interface for stethoscope
    Date Cleared
    2019-03-27

    (257 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chip Ideas Electronics S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eKuore One electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
    Device Description
    eKuore One is a system formed by eKuore One device and eKuore ONE App. The main purpose of eKuore One device is to digitalize auscultation sounds. The main purpose of eKuore ONE App is to get the acoustic signal from eKuore One device through point to point connection via USB OTG cable. The data transmission via the USB OTG cable provides high data integrity. eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use. eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected. Once eKuore One device is detected, the application identifies the device and make a connection. Once connected, the application goes to the monitor screen where the phonogram is shown in real time, the data represented in the eKuore ONE App is not processes prior to display. In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in .wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings. eKuore ONE App has a recording management screen where it is possible to play, remove and edit a recording. The edition is only for the "PatientID" and "Position". The audio data of one recording can't be modified either shared. eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration. Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.
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