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The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant

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The provided text is a 510(k) clearance letter from the FDA for the KLOCK BP Monitor. It establishes substantial equivalence to a predicate device and permits marketing. However, the document does not contain information about:

• Specific acceptance criteria for device performance.
• The study design, results, or data used to prove the device meets any acceptance criteria.
• Sample sizes for test sets, training sets, or data provenance.
• The number or qualifications of experts, adjudication methods, or ground truth establishment.
• Whether MRMC or standalone studies were conducted, or any associated effect sizes.

The letter focuses on regulatory clearance based on substantial equivalence to pre-existing devices, rather than a detailed performance study report.

Therefore, I cannot fulfill your request using the provided input as the necessary information is not present in the document.

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