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Found 10 results
510(k) Data Aggregation
K Number
K172870Device Name
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
Manufacturer
Hangzhou Hua'an medical&health instruments Co.,Ltd
Date Cleared
2018-02-13
(146 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Hua'an medical&health instruments Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.
Device Description
Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
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K Number
K172861Device Name
Digital thermometer(with disposable thermometer cover)
Manufacturer
Hangzhou Hua'an medical&health instruments Co.,Ltd
Date Cleared
2017-12-19
(90 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Hua'an medical&health instruments Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Device Description
electronic clinical thermometer
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K Number
K160999Device Name
Infra-red forehead thermometer
Manufacturer
HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD
Date Cleared
2016-08-01
(112 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models FT-100A FT-100D FT-100E are electronic clinical thermometer intended to measure human body temperature in people of all ages, its operation is based on measuring the natural thermal radiation emanating from the forehead.
Device Description
Not Found
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K Number
K122912Device Name
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2012-11-07
(47 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Device Description
Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D
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K Number
K092447Device Name
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2010-01-07
(150 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models DT Series (barring model DT-201A and DT-211A) are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
Device Description
Not Found
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K Number
K092514Device Name
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2009-12-04
(109 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Device Description
Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series
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K Number
K041693Device Name
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2004-12-02
(163 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Device Description
Not Found
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K Number
K041692Device Name
INFRARED EAR THERMOMETER, ET-100 SERIES
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2004-09-13
(83 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.
Device Description
Infrared Ear Thermometer Model ET-100 Series
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K Number
K041694Device Name
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2004-09-13
(83 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models DT-02 and DT-101 are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
Device Description
Digital Flexible Thermometer Model DT-101
Basal Digital Thermometer Model DT-02
Digital Pacifier Thermometer Model NT-01
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K Number
K030361Device Name
JASUN, MODELS DT-01F AND DT-11F
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Date Cleared
2003-02-21
(18 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices models DT-01Fand DT-11F are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Device Description
Digital Thermometer Model DT-01F & DT-11F
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