Identity
- Trade Name
- Pure EP FDA UDI
- Generic Name
- Cardiac electrophysiology analysis system FDA UDI
- Device Name
- PURE EP™ is a system 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
- AE-0001-412 FDA UDI
- Description
- PURE EP™ is a system 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-002-001-000 FDA UDI
- Primary DI / UDI-DI
- 00856750007000 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 by Biosig Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac electrophysiology analysis system.
- EP-TRACER — CardioTek B.V. · Class II
- ComboLab — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
- EMS-XL — Mennen Medical, Inc. · Class II
- EP-TRACER — CardioTek B.V. · Class II
- EMS-XL — Mennen Medical, Inc. · Class II
- ComboLab — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
- EP-TRACER — CardioTek B.V. · Class II
- Mac-Lab — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K180805 also covers:
- Pure EP - 5 x 10 pin Yoked Jumper Cable Blue — Biosig Technologies
- Pure EP - 5 x 10 pin Yoked Jumper Cable Green — Biosig Technologies
- Pure EP - 5 x 10 pin Yoked Jumper Cable White — Biosig Technologies
- Pure EP - 5 x 4 pin Yoked Jumper Cable Red — Biosig Technologies
- Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow — Biosig Technologies
- Pure EP - 5 x Single Jumper Cable Black 0.1m — Biosig Technologies
- Pure EP - 5 x Single Jumper Cable Black 0.3m — Biosig Technologies
- Pure EP - 5 x Single Jumper Cable Red 0.3m — Biosig Technologies
- Pure EP - Catheter Input Module — Biosig Technologies
- Pure EP - Catheter Input Module — Biosig Technologies
- Pure EP - Dual ECG Splitter Box — Biosig Technologies
- Pure EP - ECG Cable — Biosig Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosig Technologies
Sources (1)
- FDA UDI 45a8273d-662e-44cd-9b25-3cacc9f2929c 36 fields · synced Jun 8, 2026