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510(k) Data Aggregation
K Number
K100620Device Name
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
Manufacturer
Date Cleared
2010-07-02
(120 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HARVARD MEDICAL DEVICES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Blood Pressure Monitor, KUBE/Kinetik Branded BPM1K Series is for use by medical professionals or at home and is 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 technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Device Description
Non-Invasive Blood Pressure Measurement System
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K Number
K092558Device Name
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
Manufacturer
Date Cleared
2010-03-17
(209 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HARVARD MEDICAL DEVICES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.
Device Description
Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series
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K Number
K092557Device Name
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
Manufacturer
Date Cleared
2009-12-17
(119 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HARVARD MEDICAL DEVICES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The digital thermometer is intended to measure body temperature either orally or axillary (under the arm).
Device Description
Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series
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K Number
K081159Device Name
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
Manufacturer
Date Cleared
2008-08-08
(116 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HARVARD MEDICAL DEVICES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Kinetik BPM1 Series is for use at home and is a non-invasive blood pressurement system intended to measure the diastolic and systelle blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Device Description
Not Found
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K Number
K081061Device Name
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
Manufacturer
Date Cleared
2008-07-18
(95 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HARVARD MEDICAL DEVICES 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 neonatal, pediatric and adult population used in the home setting.
Device Description
IR Ear Thermometer HMIRET-002/Kinetik Branded IET-1 Series
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