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510(k) Data Aggregation
K Number
K180805Device Name
Pure EP
Manufacturer
Date Cleared
2018-08-08
(133 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
BioSig Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PURE EP™ is a computerized system intended for acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
Device Description
PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a high-speed 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.
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