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510(k) Data Aggregation
K Number
K973613Device Name
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
Manufacturer
Date Cleared
1998-04-14
(204 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
**FOLEY **& LARDNER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Citizen CH-611B and CH-611C digital wrist sphygmomanometers (blood pressure meters) are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse. They are intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.
Device Description
The Citizen CH-611B and CH-611C digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel to which an adjustable wrist cuff is attached by rubber tubing. The user interface panel has a power switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse, and a memory switch. The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-611B and the CH-611C is that the CH-611B has a memory function which is able to display the last measured systolic and diastolic blood pressure readings (but not the pulse) when a memory recall switch is pressed, while the CH-611C is able to display the last seven measured systolic and diastolic blood pressure readings (but not the pulse) as well as an average of the seven.
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