# K980186: Zymed Telemetry System

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies
- Decided: Oct 7, 1998 after 260 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: 1 generation back to K930806 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951370: Zymed Telemetry System; Model T8010, Zymed Medical Instrumentation (1995) Summary page 1.
- K930806: Zymed Holter Scanner Model 2010, Agilent Technologies (1994) Summary page 1.

## Most influential descendants
- K984089: Zymed Telemetry System, Model Easi View (1999), 1 descendant of its own
- K003763: 2010 Plus Holter for Windows (2001), 0 descendants of its own
- K990093: Zymed Telemetry System: Model Easiview (1999), 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 evaluation 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 Antiarrhythmic 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 arrhythmia analysis during exercise testing. Assessment is indicated for single-hospital environment.

Source page: https://510kreport.com/device/K980186
Methodology: https://510kreport.com/methodology