# K930564: Holter for Windows

- Pathway: 510(k) (Traditional)
- Applicant: North East Monitoring, Inc.
- Decided: Apr 19, 1995 after 805 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 5 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042463: Holter Plus (2004), 35 descendants of its own
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own

Source page: https://510kreport.com/device/K930564
Methodology: https://510kreport.com/methodology