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

    TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)

    K Number: K023637 · Decision Feb 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    4
    Review Days
    119

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    Basic Information

    Device Name
    TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
    K Number
    K023637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tytan Medical Corp.
    Date Received
    October 30, 2002
    Decision Date
    February 26, 2003
    Product Code
    DQD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQD Stethoscope, Electronic

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    Other Clearances by Tytan Medical Corp.

    K Number Device Name
    K092893 TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
    K062238 TYTAN BLOOD PRESSURE CUFF
    K033025 TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700