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

    ESOPHAGEAL STETHOSCOPE WITH THERMISTOR

    K Number: K862672 · Decision Oct 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    32
    Review Days
    105

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
    K Number
    K862672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inmed Corp.
    Date Received
    July 14, 1986
    Decision Date
    October 27, 1986
    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 Inmed Corp.

    K Number Device Name
    K853162 STERILE NASOPHARYNGEAL AIRWAY
    K850152 PRECONNECTED URETHRAL CATHETER TRAY
    K850335 URETEROSCOPY CATHETER
    K850248 DISPOSABLE GUEDEL AIRWAY
    K844801 ULTRA EXTERNAL CATHETER
    K842301 DISPOSABLE LATEX BANDAGE
    K842866 URETHRAL CATHETERIZATION TRAY
    K841040 FOX POST NASAL BALLOON CATHETER
    K842865 ESOPHAGEAL STETHOSCOPE
    K841037 PENROSE DRAINS
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