Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K092893
    Device Name
    TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
    Manufacturer
    TYTAN MEDICAL CORP.
    Date Cleared
    2010-01-14

    (115 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYTAN MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
    Ask a Question
    K Number
    K062238
    Device Name
    TYTAN BLOOD PRESSURE CUFF
    Manufacturer
    TYTAN MEDICAL CORP.
    Date Cleared
    2006-09-21

    (50 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYTAN MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.
    Device Description
    The TYTAN blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes. Each cuff will be packaged in a polyethylene bag.
    Ask a Question
    K Number
    K033025
    Device Name
    TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
    Manufacturer
    TYTAN MEDICAL CORP.
    Date Cleared
    2003-12-10

    (75 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYTAN MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.
    Device Description
    The device is a noninvasive blood pressure measurement system.
    Ask a Question
    K Number
    K023637
    Device Name
    TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
    Manufacturer
    TYTAN MEDICAL CORP.
    Date Cleared
    2003-02-26

    (119 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYTAN MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by Health Care Professional. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency.
    Device Description
    This electronic Stethoscope is used for the amplification of of heart, lung and other body sounds. This Stethoscope has 3 modes for selective frequency amplification & a 8-steps volume control.
    Ask a Question

    Page 1 of 1