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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.

Model CH-609 Blood Pressure Meter

The provided text is a 510(k) clearance letter for the Citizen Systems Japan Co. Ltd. Model CH-609 Blood Pressure Meter. This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

While it mentions the device's intended use and regulatory classification, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as requested in your prompt. 510(k) clearances typically reference conformity to standards (like those for blood pressure monitors) but do not include the study results directly.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval, not a technical study report.

If you have a study report or technical specifications for the Model CH-609 Blood Pressure Meter, I would be happy to analyze that document for the requested information.

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