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The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated:

• 1. non-invasive blood pressure measurement.
• 2. non-invasive blood oxygen saturation measurement using pulse oximetry,
• 3. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and
• 4. patient weight using a stand-on electronic scale;

and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.

Home Health Monitor System

The provided text is a 510(k) clearance letter from the FDA for the AvidCare Series 100 Telemanagement System (also referred to as Home Health Monitor System). It determines substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to such a study.

The document primarily focuses on the regulatory aspects of device clearance, stating its intended use and classification.

Therefore, I cannot provide the requested information based on the given text.

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