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510(k) Data Aggregation
K Number
K991458Device Name
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
Manufacturer
Date Cleared
2000-04-10
(350 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MATSUSHITA ELECTRIC CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff.
These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring medical emergencies or operations, or for any other purpose other than measuring blood pressure.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.
Device Description
MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.
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