# K982843: CMS-2000

- Pathway: 510(k) (Traditional)
- Applicant: Industrial Technology Research Institute
- Decided: Nov 10, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CMS-2000 is intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders, which principally include cardiac arrhythmia and myocardial ischemia. This recorder will document and compress the electrocardiograph signal into a memory card during 24 hours recording period with a patient.

Source page: https://510kreport.com/device/K982843
Methodology: https://510kreport.com/methodology