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The Home Health Monitoring System is intended for use as a monitoring device, whereby a health care professional can view and communicate with the patient between offices visits to collect readings of patient blood pressure, the manage, pulse, temperature, and listen to sounds emanating from the bowel, heart and lungs.

The system is contraindicated for two populations. Patient's and/or caregivers that are physically unable to use this device. Patients' and/or caregivers who's cognitive and or language skills are impaired to such an extent as to preclude communication with medical personnel or effectively operate the device

This device should not be used for continuos monitoring.

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The provided document is a 510(k) clearance letter from the FDA for the Kodak LifeView Telemonitoring System. It does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes for testing or training sets, expert qualifications, or ground truth establishment methods typically found in clinical study reports or pre-market approval applications.

Therefore, I cannot provide the requested information based on the input text. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory obligations.

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