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Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure by detecting Korotkoff sound. This product is only for adult use.

The proposed device, Caremate Sphygmomanometer with Stethoscope, is a non-invasive and non automated device intended to measure the blood pressure. It contains of a cuff with inflatable bladder and an aneroid manometer to measure the pressure, as well as a stethoscope for detecting the Korotkoff sound; In addition, an end valve, an air release valve and a bulb are included to complete its function. Caremate Sphygmomanometer with Stethoscope has two models, CM-BPM and CM-PBPM. They are following the same design principle and same components. The only differences are that the bulb and the aneroid manometer are connected together. The operator can held them in one hand. This design feature facilitates the using of this device and will not affect the performance. This product is provided non-sterile and only for adult use.

The provided text describes the Caremate Sphygmomanometer with Stethoscope, but it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested.

The document is a 510(k) summary for a medical device submission to the FDA. It states that "Laboratory testing was conducted to validate and verify that the proposed device, Caremate Sphygmomanometer with Stethoscope, both CM-BPM and CM-PBPM met all design specifications and was substantially equivalent to the predicate device." However, it does not provide the acceptance criteria used in this laboratory testing, the results obtained, or any details about the study methodology. It also explicitly mentions that "No Clinical Information is required."

Therefore, I cannot populate the table and answer the questions as requested. The information is simply not present in the provided text.

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