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510(k) Data Aggregation
K Number
K093359Device Name
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
Manufacturer
Date Cleared
2009-11-27
(30 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI LITTLE DOCTOR CO. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The subjects are intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.
Device Description
The Digital Blood Pressure Monitors, Model LD1103 and LD 1133, are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and to calculate pulse rate, which is a well-known technique in the market called the "oscillometric method". The device can analyze the signals promptly and display the results.
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K Number
K092683Device Name
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
Manufacturer
Date Cleared
2009-09-25
(24 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI LITTLE DOCTOR CO. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.
Device Description
The Digital Wrist Blood Pressure Monitor, Model LD1143, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist. The method to define systolic and diastolic pressure is. similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and to calculate pulse rate, which is a well-known technique in the market called the "oscillometric method". The device can analyze the signals promptly and display the results. The modified device has two new auxiliary features called WHO indication and date and time display.
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