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Found 4 results
510(k) Data Aggregation
K Number
K102303Device Name
BLOOD PRESSURE METER, MODEL CH-658
Manufacturer
Date Cleared
2010-09-10
(25 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CITIZEN SYSTEMS JAPAN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Device Description
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K Number
K100055Device Name
BLOOD PRESSURE METER, MODEL CH-609
Manufacturer
Date Cleared
2010-08-30
(234 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CITIZEN SYSTEMS JAPAN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Model CH-609 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Device Description
Model CH-609 Blood Pressure Meter
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K Number
K093931Device Name
BLOOD PRESSURE METER, MODEL CH-4532
Manufacturer
Date Cleared
2010-06-10
(170 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CITIZEN SYSTEMS JAPAN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Device Description
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K Number
K100553Device Name
BLOOD PRESSURE METER MODEL CH-101
Manufacturer
Date Cleared
2010-05-25
(88 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CITIZEN SYSTEMS JAPAN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Model CH-101 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Device Description
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