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

    SHERIDAN - YSI/ECG SONATEMP (TM)

    K Number: K861541 · Decision Jun 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    39
    Review Days
    53

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    Basic Information

    Device Name
    SHERIDAN - YSI/ECG SONATEMP (TM)
    K Number
    K861541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sheridan Catheter Corp.
    Date Received
    April 24, 1986
    Decision Date
    June 16, 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 Sheridan Catheter Corp.

    K Number Device Name
    K922894 LAZER-TRACH TRACHEAL TUBE
    K897046 LASER RESISTANT TRACHEAL TUBE
    K890823 ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
    K884765 CLINICAL ELECTRONIC THERMOMETERS
    K882918 KIM NASO-INTESTINAL TUBE
    K882127 CLINICAL ELECTRONIC THERMOMETERS
    K881368 CLINICAL ELECTONIC THERMOMETERS
    K881293 SHERIDAN ELECTROSURGERY PROTECTION FILTER
    K881873 INTRODUCTION/DRAINAGE CATHETER & ACCESS
    K880960 NDYAG LASER TRACHEAL TUBE
    Search all 39 clearances from Sheridan Catheter Corp. →