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Pure EP - Dual ECG Splitter Box

FDA UDI

Class II (US FDA UDI)

by Biosig Technologies

Identity

Trade Name
Pure EP - Dual ECG Splitter Box FDA UDI
Generic Name
Cardiac electrophysiology analysis system FDA UDI
Device Name
The Dual ECG Splitter Box is an accessory to the PURE EP™ System. It allows splitting a single array of input ECG signals into two output signals to use in conjunction with the PURE EP™ system. 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. FDA UDI
Model / Reference
PE-002-021-000 FDA UDI
Description
The Dual ECG Splitter Box is an accessory to the PURE EP™ System. It allows splitting a single array of input ECG signals into two output signals to use in conjunction with the PURE EP™ system. 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. FDA UDI

Identifiers

Catalog Number
PE-002-021-000 FDA UDI
Primary DI / UDI-DI
00856750007123 FDA UDI
510(k) Number
K180805 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac electrophysiology analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac electrophysiology analysis system

Pure EP - Dual ECG Splitter Box by Biosig Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac electrophysiology analysis system.

Cleared under the same submission

K180805 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biosig Technologies

Sources (1)

  • FDA UDI 9d480211-9a65-469b-b2ab-f4da7d17f53d 36 fields · synced Jun 8, 2026