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

    ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR

    K Number: K843071 · Decision Aug 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    14
    Review Days
    18

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
    K Number
    K843071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Primrose Medical, Inc.
    Date Received
    August 6, 1984
    Decision Date
    August 24, 1984
    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 Primrose Medical, Inc.

    K Number Device Name
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    K884711 URETHRAL AND URETERAL BALLOON DILATATORS
    K884709 ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
    K884712 ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
    K883420 LANCET, BLOOD
    K881976 CATHETER, INTRAVASCULAR
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