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510(k) Data Aggregation
K Number
K221913Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2022-10-12
(104 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical Shenzhen,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
Device Description
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K Number
K210565Device Name
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
Manufacturer
Date Cleared
2022-05-05
(434 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical Shenzhen,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Thermometer is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.
Device Description
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K Number
K212877Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2022-01-12
(125 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical Shenzhen,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
Device Description
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K Number
K210563Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2021-10-15
(232 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical Shenzhen,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults who over the age of 12.
Device Description
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