# K021470: Seer Light Compact Digital Holter Recorder

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Nov 14, 2002 after 190 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K001317 (2000). 1 ancestor in all.
24 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001317: ARIA, Del Mar Medical Systems, LLC (2000)

## Most influential descendants
- K073545: Audicor, Hemo Ambulatory Monitor (2008), 11 descendants of its own
- K050731: Seer Light Extend Compact Digital Holter System (2005), 10 descendants of its own
- K112921: Medicalgorithmics Unified Arrhythmia Diagnostic System (2012), 7 descendants of its own
- K124060: Medical Gorithmics Unified Arrhythmia Diagnostic System (2013), 5 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own

## Indications for use
The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data. The SEER Light Compact Digtal Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Source page: https://510kreport.com/device/K021470
Methodology: https://510kreport.com/methodology