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510(k) Data Aggregation
K Number
K190927Device Name
Oscillometric Blood Pressure Monitor
Manufacturer
Rudolf Riester GmbH
Date Cleared
2019-06-24
(76 days)
Product Code
DXN
Regulation Number
870.1130Why 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.
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K Number
K170538Device Name
RVS-100 Vital Signs Monitor
Manufacturer
Rudolf Riester GmbH
Date Cleared
2017-10-17
(236 days)
Product Code
MWI
Regulation Number
870.2300Why 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.
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K Number
K171182Device Name
ri-former Predictive Thermometer
Manufacturer
Rudolf Riester GmbH
Date Cleared
2017-10-04
(163 days)
Product Code
FLL
Regulation Number
880.2910Why 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.
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K Number
K002954Device 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
870.1120Why did this record match?
Applicant Name (Manufacturer) :
RUDOLF RIESTER GMBH & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002955Device Name
EMPIRE N BLOOD PRESSURE MANOMETERS
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
2000-12-21
(90 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
RUDOLF RIESTER GMBH & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972377Device Name
RI-MEGA
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
1997-09-24
(90 days)
Product Code
DXQ
Regulation Number
870.1120Why 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
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K Number
K972378Device Name
SANAPHON N
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
1997-09-24
(90 days)
Product Code
DXQ
Regulation Number
870.1120Why 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
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K Number
K972379Device Name
PRECISA N
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
1997-09-24
(90 days)
Product Code
DXQ
Regulation Number
870.1120Why 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
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K Number
K972301Device 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
870.1120Why 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
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K Number
K964338Device 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
886.1780Why did this record match?
Applicant Name (Manufacturer) :
RUDOLF RIESTER GMBH & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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