# K983928: Kodak Home Health Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Feb 11, 2000 after 463 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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, Iinsamismamgen. 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.

Source page: https://510kreport.com/device/K983928
Methodology: https://510kreport.com/methodology