# K000404: PC ECG 1200

- Pathway: 510(k) (Traditional)
- Applicant: Norav Medical, Ltd.
- Decided: Nov 22, 2000 after 289 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K080141: PC Ecg 1200W System (2008), 3 descendants of its own
- K042981: Hyperq System (2005), 2 descendants of its own
- K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb (2010), 1 descendant of its own
- K070624: Hyperq System (2007), 1 descendant of its own
- K142352: CardiacLinx (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K000404
Methodology: https://510kreport.com/methodology