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RH non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory. depending on the model.

RH non-Automated Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL Max02, Max0201, Max0202, Max0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model Max0202, Max0203 include additional Stethoscope (Single head, Dual head and Sprague Rappaport). It is conjunction with Stethoscope when use.

The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is made of Nylon Cloth or Cotton Cloth can be selected according to user's need.

The document provided is a 510(k) Pre-market Notification from the FDA for a non-automated blood pressure meter. It declares substantial equivalence to a predicate device and does not contain specific acceptance criteria, detailed study results, or performance data for the device in question ("RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203").

Therefore, I cannot provide the requested information. The document explicitly states:

• Clinical Study: "No clinical study is included in this submission." (Page 9)
• Performance: It mentions that "All performance specification of new devices for various cuff sizes were verified to comply with the ISO81060-1 standard." (Page 9) and "Performance compatible as requirement of ISO 81060-1" (Page 4) but does not provide the actual results or acceptance criteria from these tests. It only lists the accuracy requirement from the standard as "+/- 3 mmHg of reading."

The acceptance criteria and study proving the device meets them are not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, largely through a comparison of general characteristics and adherence to recognized standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

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