(307 days)
The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.
Medline Single Patient Use Blood Pressure Cuffs:
Neonatal, single tube
Neonatal, double tube
Infant - Adult, Disposable double tube
Infant - Adult, Disposable single tube
The provided text is a 510(k) clearance letter from the FDA for Medline Single Patient Use Blood Pressure Cuffs. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot answer your request based on the provided text. The document is a regulatory approval letter, not a scientific study report.
§ 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).