(335 days)
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.
The provided text is a 510(k) clearance letter from the FDA for an Aneroid Sphygmomanometer. It declares the device substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter only states that the device is "substantially equivalent" to a predicate device and can therefore be marketed. To provide the requested information, a different type of document (e.g., a summary of safety and effectiveness, or a full study report) would be needed.
Therefore, I cannot fulfill your request based on the provided input.
§ 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).