(100 days)
The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.
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The provided text is a 510(k) premarket notification acceptance letter from the FDA to Rossmax International Ltd. for their Digital Sphygmomanometer MANDAUS II. It's a regulatory document and does not contain the detailed study results or acceptance criteria and device performance table typically found in scientific publications or clinical study reports.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific performance criteria or the study that demonstrates compliance.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).