BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ESOPHAGEAL STETHOSCOPE

    K Number: K930929 · Decision Mar 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    752

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE
    K Number
    K930929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coast Medical Corp.
    Date Received
    February 23, 1993
    Decision Date
    March 17, 1995
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by Coast Medical Corp.

    K Number Device Name
    K930930 COAST MEDICAL, INC. RECTAL PROBE
    K925781 DISPOSABLE CUFFED ENDOTRACHEAL TUBE
    K925855 DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
    K921077 DISPOSABLE INTUBATION KITS
    K921353 NASOPHARYNGEAL AIRWAY