BUR250c 12-Lead Multi-Channel Electrocardiograph - Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module; current software, Adult and Pediatric Interpretation, Standard storage (up to 40 ECGs), LAN + WLAN; International power cord, IEC 10 wire, 12-lead lead set with banana plugs, ECG clip adapters (set of 10) and Mortara tab electrodes (pouch of 100), starter pack A4 paper with spacer for writer tray


Product Overview

BUR250c 12
Welch Allyn, Inc. - 901131


Device Description

A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: DPS

Device Name: Electrocardiograph

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2340

Third Party Flag: Y

Medical Specialty: CV


Device Identifiers

Device Id: 00732094271713

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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