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510(k) Data Aggregation

    K Number
    K982193
    Device Name
    ESOPHAGEAL STETHOSCOPE
    Manufacturer
    SHORE MEDICAL, INC.
    Date Cleared
    1998-09-01

    (71 days)

    Product Code
    BZT
    Regulation Number
    868.1920
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHORE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.
    Device Description
    Esophageal Stethoscope
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