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The BpTRU:

• Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
• age of officials' offices, nursing units, and patient care areas of ● hospitals.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the BpTRU Automated Non-Invasive Blood Pressure Monitor. It determines substantial equivalence to a predicate device and allows the device to be marketed.

However, the document does not contain any information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details based on the given input. The information necessary to answer the prompt is not present in the provided FDA letter.

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The BPM-100:

• Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age.
• Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.

Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

The provided text is an FDA 510(k) clearance letter for an "Automated Non-Invasive Blood Pressure Monitor, Model BPM-100". It merely states that the device is substantially equivalent to legally marketed predicate devices and is approved for market.

Crucially, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot provide the requested information. To answer your questions, I would need access to the actual 510(k) submission summary or detailed study reports for the BPM-100 device.

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