The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on…
The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on the amplifier (aka MSU – Main System Unit). The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU – Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Pure EP – ECG Cable | Listed by | Biosig Technologies, United States |
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| 510(k) | K180805 |
| Record published | 2021-06-30 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.