Search Results
Found 3 results
510(k) Data Aggregation
K Number
K123839Device Name
WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
Manufacturer
Date Cleared
2013-01-11
(29 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NINGBO DIAIER ELECTRONIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WA100WA200MA300/WB100/WB200/WD100/WE100/WF100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use (without the involvement of professional physician)
AA100/AA200/AB100/AC100/AD100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use (without the involvement of professional physician)
Device Description
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base:
- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric . method).
- · · Heart beat rate.
For this submission, two different types of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WD100/WE100/WF100/WB200 and A series upper arm type/model AÁÍ00/AA200/AD100/AC100/AF100/AE100/AC200/AC300.
In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200WA300/WB100/WB200/ WD100/WE100/WF100 and A series opper arm type/model AA100/AA200/AB100/AC100/AD100 blood pressure monitors provide also the mpen an function for user to store the result of measurement.
Ask a Question
Ask a specific question about this device
K Number
K093739Device Name
BLOOD PRESSURE MONITOR/ MODELS
Manufacturer
Date Cleared
2010-05-07
(154 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NINGBO DIAIER ELECTRONIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WA100/WA200/WA300/WB100/WB200/WD100/WE100/WF100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)
AA100/AA200/AB100/AC100/AD100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use( without the involvement of professional physician)
Device Description
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :
- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
- Heart beat rate.
For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WA300/WB100/ WB200/WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/ AB100/AC100/AD100.
In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200/WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/AC100/AC100/AD100 blood pressure monitors provide also the memory function for user to store the result of measurement.
Ask a Question
Ask a specific question about this device
K Number
K091553Device Name
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
Manufacturer
Date Cleared
2009-09-21
(117 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NINGBO DIAIER ELECTRONIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WA400 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)
AA300 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).
Device Description
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on,
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :
Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
Heart beat rate.
For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type of blood pressure monitor is as the description of the following section:
In addition to the main blood pressure and heart beat rate measuring function, the WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.
Ask a Question
Ask a specific question about this device
Page 1 of 1