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Found 4 results
510(k) Data Aggregation
K Number
K132140Device Name
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
Manufacturer
Date Cleared
2014-02-04
(208 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
DUTECK INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCD
The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.
Device Description
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
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K Number
K060642Device Name
DUTECK BODY COMPOSITION ANALYZER
Manufacturer
Date Cleared
2006-06-07
(89 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
DUTECK INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
Device Description
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis).
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K Number
K021601Device Name
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
Manufacturer
Date Cleared
2002-07-10
(56 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
DUTECK INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.
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K Number
K992327Device Name
DUTECK DIGITAL CLINICAL THERMOMETER
Manufacturer
Date Cleared
1999-08-18
(37 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
DUTECK INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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