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Found 7 results
510(k) Data Aggregation
K Number
K232338Device Name
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
Manufacturer
Date Cleared
2023-12-22
(140 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 Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.
Device Description
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
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K Number
K231050Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2023-10-11
(181 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
K230649Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2023-09-07
(182 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
Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.
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K Number
K222248Device Name
Infrared Thermometer
Manufacturer
Date Cleared
2023-06-07
(316 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 (model of AET-R612W.AET-R612G.AET-R612A.AET-R612B.AET-R612C) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from ear canal or non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.
Device Description
Not Found
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K Number
K210937Device Name
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
Manufacturer
Date Cleared
2022-05-12
(409 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 Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.
Device Description
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
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K Number
K212257Device Name
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
Manufacturer
Date Cleared
2022-05-04
(289 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 Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.
Device Description
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K Number
K210564Device Name
Infrared Thermometer
Manufacturer
Date Cleared
2022-01-07
(316 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 (model of AET-R811,AET-R832,AET-R842,AET-R852,AET-R862) is intended for measuring human body temperature of people aged 3 months and above by detecting infract contact with the forehead and ear canal in the home or hospital environment.
The Infrared Thermometer (model of AET-R101, AET-R151, AET-R1A3, AET-R1A6, AET-R1C1) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from the ear canal in the home or hospital environment.
Device Description
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