(56 days)
The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.
The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.
The provided document does not contain any information about acceptance criteria, device performance, or related studies. It is a K051539 510(k) clearance document for a blood pressure cuff and primarily focuses on administrative details, intended use, and the FDA's substantial equivalence determination.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 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).