# K042849: Cardio Spectrum Diagnostic System (CSD)

- Pathway: 510(k) (Traditional)
- Applicant: Cardiobiomedical Corporation
- Decided: Jan 13, 2005 after 90 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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
The Cardio Spectrum Diagnostic System is intended to be used as an aid to diagnosis by means of analysis of the ECG waveform in the frequency domain (power spectral estimate).

Source page: https://510kreport.com/device/K042849
Methodology: https://510kreport.com/methodology