Search Results

The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Not Found

This document is an FDA 510(k) clearance letter for an Arm Blood Pressure Monitor. It primarily covers administrative details, regulatory classifications, and general compliance requirements. It does not contain the detailed acceptance criteria or study results for device performance that would be found in a clinical study report or a summary of safety and effectiveness.

Therefore, I cannot provide the requested information based on the provided text. The document is essentially a regulatory approval notice, not a technical performance report.

To answer your prompt, I would need a different type of document, such as:

• A clinical study report
• A premarket submission summary (e.g., a 510(k) summary that includes performance data)
• A design validation report

Without such a document, I am unable to describe the acceptance criteria and the study that proves the device meets them as requested in the prompt.

Ask a specific question about this device

The Infrared Thermometer is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Alicn Medical Shenzhen, Inc. Infrared Thermometer (K210565) does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device, the applicable regulations, and administrative instructions. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement in testing.
• Information on MRMC studies or effect sizes.

To obtain this information, you would typically need to refer to the Premarket Notification (510(k)) Summary or the Device Description document submitted by the manufacturer to the FDA, which are sometimes publicly available through the FDA's 510(k) database if the manufacturer chooses to make them so, or if they are released under a Freedom of Information Act (FOIA) request.

The provided document is merely the FDA's clearance letter, not the underlying test reports or summary data.

Ask a specific question about this device

The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Not Found

This FDA 510(k) clearance letter for the Alicn Medical Shenzhen,Inc Arm Blood Pressure Monitor does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines the regulatory obligations of the manufacturer and specifies the "Indications for Use" for the blood pressure monitor.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.

This type of detailed study information is typically found in the 510(k) submission itself (which is not publicly available in its entirety, though a summary is), or in associated clinical trial reports, rather than in the FDA's clearance letter.

Ask a specific question about this device

The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults who over the age of 12.

Not Found

I am sorry, but the provided text only refers to the FDA's decision regarding the substantial equivalence of the Arm Blood Pressure Monitor to legally marketed predicate devices. It does not contain information about the device's acceptance criteria, reported performance, or the details of any studies conducted. Therefore, I cannot provide the requested information.

Ask a specific question about this device