# K984089: Zymed Telemetry System, Model Easi View

- Pathway: 510(k) (Traditional)
- Applicant: Zymed Medical Instrumentation
- Decided: Feb 16, 1999 after 92 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K003763: 2010 Plus Holter for Windows (2001), 0 descendants of its own

## 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 Antiarthythmia 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 is indicated for single-hospital environment. Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters. Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 Ib) Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/b.)

Source page: https://510kreport.com/device/K984089
Methodology: https://510kreport.com/methodology