Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K190927
    Device Name
    Oscillometric Blood Pressure Monitor
    Manufacturer
    Rudolf Riester GmbH
    Date Cleared
    2019-06-24

    (76 days)

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

    Rudolf Riester GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This oscillometric blood pressure monitor is intended to measure the systolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels. This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 3 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.
    Device Description
    The proposed device, oscillometric blood pressure monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure of the person aged 3 years or older at upper arm within its claimed range and accuracy via the oscillometric technique. The proposed oscillometric blood pressure monitor is available in one model, RBP 100. Three sizes of cuffs are provided with proposed device, which are S size, M size and L-XL size: 14~22cm; M size: 22~32cm; L-XL size: 32~52cm). The proposed device is intended to be used in medical facilities.
    Ask a Question
    K Number
    K170538
    Device Name
    RVS-100 Vital Signs Monitor
    Manufacturer
    Rudolf Riester GmbH
    Date Cleared
    2017-10-17

    (236 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rudolf Riester GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RVS-100 vital signs monitor is intended to be used for monitoring, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Noninvasive Blood Pressure (NIBP), and Temperature (Temp). The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.
    Device Description
    The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The RVS-100 is a portable device, consist of main unit and accessories, including NIBP cuff, Temperature sensor, and SpO2 sensor. RVS-100 vital signs monitor has a DC power connector, RVS-100 can connect with extension device RVS-200 and supply power for RVS-200 through the DC power connector.
    Ask a Question
    K Number
    K171182
    Device Name
    ri-former Predictive Thermometer
    Manufacturer
    Rudolf Riester GmbH
    Date Cleared
    2017-10-04

    (163 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rudolf Riester GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used for measuring body temperature in the mouth (oral) in the anus (rectal) and in the armpit (axillary). It is intended for adults, children and infants.
    Device Description
    The ri-former® Predictive Thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The thermometer is driven by the power supply of our ri-former® diagnostic station. There are rectal (red) and oral, axillary (blue) probes available. To prevent from cross contamination the thermometer needs to be used with disposable probe covers. The thermometer can be used for the temperature measurement of all patients and is designed for the use in hospitals, clinics, medical practices or similar facilities.
    Ask a Question
    K Number
    K002954
    Device Name
    RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    2000-12-21

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002955
    Device Name
    EMPIRE N BLOOD PRESSURE MANOMETERS
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    2000-12-21

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K972377
    Device Name
    RI-MEGA
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-09-24

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure
    Device Description
    Ri-Mega is a sphygmomanometer
    Ask a Question
    K Number
    K972378
    Device Name
    SANAPHON N
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-09-24

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)
    Device Description
    Sanaphon-N is a sphygmomanometer
    Ask a Question
    K Number
    K972379
    Device Name
    PRECISA N
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-09-24

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)
    Device Description
    Precisa-N is a sphygmomanometer
    Ask a Question
    K Number
    K972301
    Device Name
    BIG BEN SQUARE, BIG BEN ROUND
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-09-17

    (90 days)

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

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.
    Device Description
    Not Found
    Ask a Question
    K Number
    K964338
    Device Name
    RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-01-09

    (70 days)

    Product Code
    HKM
    Regulation Number
    886.1780
    Why did this record match?
    Applicant Name (Manufacturer) :

    RUDOLF RIESTER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1