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510(k) Data Aggregation
K Number
K230176Device Name
Upper Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2023-06-29
(157 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yolanda Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~42 cm or 22cm~48cm. It is intended to be used in hospital environment or at home.
Device Description
Upper Arm Blood pressure Monitor (Model:SP10A).
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K Number
K221211Device Name
Infrared thermometer
Manufacturer
Date Cleared
2022-09-27
(153 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yolanda Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared thermometer is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear canal or by the center of forehead(non-contact type) for people of all ages.
Device Description
Not Found
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K Number
K221212Device Name
Upper Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2022-08-26
(121 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yolanda Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
Device Description
Upper Arm Blood pressure Monitor, Model SP10A
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