# K990093: Zymed Telemetry System: Model Easiview

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies
- Decided: May 11, 1999 after 120 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930806 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980186: Zymed Telemetry System, Agilent Technologies (1998) Summary page 1.
- K930004: Escort 100/300 Series B Patient Monitors, Medical Data Electronics (1993) Summary page 1.

## Indications for use
Assessment of symptoms that may be related to rhythm disturbances of the heart; Patients with palpitations; The evaluations of arrhythmia’s in patients from pediatric to adult age. Assessment of risk in patients with or without symptoms of arrhythmia. Assessment of efficacy of Antiarrhythmia therapy. Assessment of Pacemaker Function. Assessment of real time ST segment analysis. Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmias analysis during exercise testing. Assessment of transferred SpO2 level data from an MDE Escort Bedside monitor to EasiView for display and alarm., Assessment of transferred invasive and Non-invasive blood pressure, both systolic and diastolic, data from an MDE Escort Bedside monitor to EasiView for display and alarm. Assessment of transferred temperature parameter data from an MDE Escort Bedside monitor to EasiView for display and alarm. Assessment of transferred respiration data from an MDE Escort Bedside monitor to EasiView for display. Assessment is indicated for single-hospital environment.

Source page: https://510kreport.com/device/K990093
Methodology: https://510kreport.com/methodology