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510(k) Data Aggregation

    K Number
    K233313
    Device Name
    Keikku Electronic stethoscope
    Manufacturer
    Lapsi Health Holding B.V
    Date Cleared
    2024-04-10

    (194 days)

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

    Lapsi Health Holding B.V

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keikku is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation data of the patient (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on a network can listen to the auscultation data of a patient on site or at a different location on the network. The Keikku is intended for use on pediatric and adult patients. The Keikku is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
    Device Description
    The Keikku (Rx) is a digital stethoscope device designed for use by health care professionals in clinical settings and by lay users in non-clinical environments under healthcare provider supervision. The Keikku electronically amplifies, filters and transfers body sounds through the accompanying mobile application and is used for storage, sharing and transmitting the data for telemedicine use. It also enables lay users, under supervision from a healthcare provider, to listen to their body sounds (lungs, heart, arteries, veins, gastrointestinal tract, etc.), record and share it with their physicians during telehealth sessions. The Keikku consists of two primary components: 1. The Keikku device is an electronic stethoscope. The Keikku device is used for recording audio, converting it to digital data, and transmitting the data to a mobile device via Bluetooth®. It includes volume adjustment via rotation, tap feature for starting and ending the recording, and an LED light indicator for indicating the status of the device. 2. The Keikku App. The app captures audio data from the Keikku device and provides data visualization and annotation, secure data storage, audio playback, and sharing features. These features enable a healthcare professional to monitor patients, seek second opinions from a specialist or use the device for telemedicine use.
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