BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    TYTAN BLOOD PRESSURE CUFF

    K Number: K062238 · Decision Sep 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    4
    Review Days
    50

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    Basic Information

    Device Name
    TYTAN BLOOD PRESSURE CUFF
    K Number
    K062238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tytan Medical Corp.
    Date Received
    August 2, 2006
    Decision Date
    September 21, 2006
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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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
    K033025 TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
    K023637 TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)