MAC 600

Primary DI

00840682134859

Basic UDI-DI Code

8406821BUG00169HM

Reference

2042216-003

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

GE Medical Systems Information Technologies, Inc.

The MAC 600 Resting ECG Analysis System is intended to perform ECG acquisition, analysis and recording. It can display 3, 6 or 12 leads of ECG data and can print the ECG data 3 leads at a time. The MAC 600 can be upgraded to provide software analysis options such as 12-lead interpretive analysis and 12-lead resting ECG measurement and interpretation utilizing the Marquette 12SL ECU Analysis program. Transmission of ECG data to a central ECG cardiovascular information system is also optional. The MAC 600 delivers multiple leads of ECG on reports and includes a numeric keypad, and function keys for entering patient ID and other data entry. There is an integrated colour display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data, and non-real time reports. The device has removable memory storage to store resting ECG records. The device also can export the resting ECG record to an XML or PDF file on an SD card. The MAC 600 can be run-off of a rechargeable lithium-ion battery to allow it to be used as a portable unit.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).