# K032200: Elan Digital 12 Channel Electrocardiograph

- Pathway: 510(k) (Abbreviated)
- Applicant: Remco Italia S.P.A.
- Decided: Oct 3, 2003 after 77 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K895520 (1990). 5 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio, Hewlett-Packard Co. (1996) Summary page 1.
- K010505: Telemed 12 Lead Resting Ecg Analysis Library, Brentwood Medical Technology Corp. (2001)
- K880357: Omnigraph 6000, Telemed Div. (1988) Summary page 1.

## Most influential descendants
- K072353: Portable Ecscope (2007), 5 descendants of its own
- K080036: Portable Ecscope 12I (2008), 2 descendants of its own
- K082013: Clue Medical and Clue Medical Basic (2008), 1 descendant of its own
- K091397: Ecscope 200 (2009), 0 descendants of its own
- K091358: Ecscope 100 (2009), 0 descendants of its own

## Indications for use
ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

Source page: https://510kreport.com/device/K032200
Methodology: https://510kreport.com/methodology