# K992584: PE 501 PC-Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nhe Corp.
- Decided: Jan 13, 2000 after 164 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
Longest line of descent: 2 generations back to K923930 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720, Braemar Corp. (1998) Summary page 1.
- K963578: PC Based Electrocardiograph System (PC-Ecg), Intl. Products, Inc. (1997) Summary page 1.

## Indications for use
The PE 501 PC-ECG is indicated for acquiring and displaying 2 channel ECG signals through a personal computer and transferring the recorded ECG signals to a remote computer. It is designed for stationary use and is not for ambulatory use. It is intended for use primarily in out-patient clinics. The PE 501 PC-ECG device should be operated by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K992584
Methodology: https://510kreport.com/methodology