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Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

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The provided text is a 510(k) premarket notification decision letter from the FDA to Zefon International regarding their VitalCheck Blood Pressure Cuff, NIBP Tubing, and Adapters.

This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document stating that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from the provided text.

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The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

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This document is a 510(k) clearance letter for the Zefon DuraCheck Blood Pressure Cuffs. It indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert evaluations.

Therefore, based solely on the provided text, I cannot answer any of the questions regarding acceptance criteria, study details, and performance. The document focuses on regulatory clearance, not performance data.

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