# K972199: Signal-Averaged High Resolution P Wave Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Sep 25, 1997 after 106 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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) Marquette High Resolution ECG Option for MAC-Series Electrocardiographs: named in the summary without a submission number

## Indications for use
PHi-Res is a software option for Marquette ECG analysis systems for high resolution P wave analysis. PHi-Res is intended to be used in a hospital or clinic environment by health care professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis. PHi-Res analysis is only intended to provide the measurements of the signal averaged P wave and is not intended to provide any interpretation of those measurements or any kind of diagnosis. The P wave measurements provided by PHi-Res analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with patient’s clinical history, symptoms, other diagnostic tests, as well as the professional’s clinical judgment. PHi-Res is intended for patient populations including adult and pediatric.

Source page: https://510kreport.com/device/K972199
Methodology: https://510kreport.com/methodology