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510(k) Data Aggregation
K Number
K042818Device Name
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
Manufacturer
Date Cleared
2005-01-27
(107 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MATSUSHITA ELECTRIC WORKS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 are devices intended to measure the systolic and diastolic 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.
For the EW 3037, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure", U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure.
The EW 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Device Description
Panasonic Wrist Blood Pressure Monitor Models EW3003 and EW3037
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K Number
K033894Device Name
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
Manufacturer
Date Cleared
2004-03-11
(86 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MATSUSHITA ELECTRIC WORKS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 are devices intended to measure the systolic and diastolic 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.
For the EW 3032, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure" , U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure.
The EW 3032 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Device Description
The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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 calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
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