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

    VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE

    K Number: K885347 · Decision Jan 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    33

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
    K Number
    K885347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Vitacomm, Inc.
    Date Received
    December 28, 1988
    Decision Date
    January 30, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BZT), ordered by most recent decision date.

    Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESOPHAGEAL STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Vitacomm, Inc.

    K Number Device Name
    K842309 VITACOMM 100 ESOPHAGEAL STETHOSCOPE