Search Results

The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.

I am sorry, but the provided text does not contain the detailed information needed to fully answer your request regarding the acceptance criteria, study details, and sample sizes for the medical device described. The document is a 510(k) summary for a Disposable NIBP Cuff, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of what is and is not in the text, relative to your request:

What is present in the document:

• Acceptance Criteria (Indirectly): The document states that "Non-clinical tests were conducted to verify that the subject device met all design specifications" and that it complies with "ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007." This standard would implicitly define the performance acceptance criteria for blood pressure cuffs. However, the specific numerical acceptance criteria (e.g., maximum allowable error in mmHg) are not explicitly listed in the provided text. The "Max. Leakage" of "

Ask a specific question about this device