# K964036: Cardiomagic 2000 Software

- Pathway: 510(k) (Traditional)
- Applicant: Instromedix, Inc.
- Decided: Jul 18, 1997 after 283 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Previous CardioMagic products: named in the summary without a submission number
- (no number) PaceArt CPTS: named in the summary without a submission number
- (no number) PaceBase: named in the summary without a submission number

## Most influential descendants
- K982384: Mercator (1999), 7 descendants of its own
- K013354: Globalcardio (2002), 5 descendants of its own
- K033037: Modification to Globalcardio (2003), 4 descendants of its own
- K111320: Globalcardio (2011), 3 descendants of its own
- K122632: Guava II (2014), 2 descendants of its own

## Indications for use
Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention. In-office acquisition and display of single and/or multi-lead ECG. Collection, storing, reporiing, transfer, and management of patient{s) health information.

Source page: https://510kreport.com/device/K964036
Methodology: https://510kreport.com/methodology