GE MAC VU360 Resting ECG Analysis System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GE HEALTHCARE PTE. LTD.

Class:

Class B medical device

Manufactured by:

GE Medical Systems Information Technologies, Inc

Therapeutic area:

Cardiovascular

Therapeutic indications:

The system is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed, or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. The system is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Product summary:

Device System Info:[System or Procedure Pack], Please refer to section "Description of intended use" above.; Models: MAC VU360 - 2030360-001, CAM Connect 14 with Barcode - 2091685-001, CAM Connect 14 - 2091686-001

Authorization date:

2018-10-15