# K992703: Cardiotron Ekg Multi-Phase Information Analysis System, Models 3800, 6800, 8800

- Pathway: 510(k) (Traditional)
- Applicant: Premier Heart, LLC
- Decided: Mar 21, 2000 after 222 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. The FDA summary names its predicate without a number.
- (no number) New York Heart Instrument Inc.'s EKG Multi-Phase Information Diagnosis System, Model FFF-IA: named in the summary without a submission number

## Indications for use
The Cardiotron Multi-Phase EKG Information Apalysis System is intended to be used as an aid to diagnosis by means of analysis of the EKG waveform in the frequency domain (power spectral estimate).

Source page: https://510kreport.com/device/K992703
Methodology: https://510kreport.com/methodology