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510(k) Data Aggregation

    K Number
    K011898
    Device Name
    E-STETH ELECTRONIC STETHOSCOPE
    Date Cleared
    2001-09-14

    (88 days)

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

    E-MED INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software earphones, and a communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.
    Device Description
    The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software; earphones, and communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.
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