GE MARS™ Ambulatory ECG System

Singapore - English - HSA (Health Sciences Authority)

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Available from:
GE HEALTHCARE PTE. LTD.
Class:
Class C medical device
Manufactured by:
GE Medical Systems Information Technologies
Therapeutic area:
Cardiovascular
Therapeutic indications:
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and Holter analysis capabilities.
Product summary:
Device System Info:[System or Procedure Pack], System or Procedure Pack; Models: MARS8 - 2047314-001, Hardware /Software System Configurations - 2047314-014, Hardware /Software System Configurations - 2047314-016, Hardware /Software System Configurations - 2047314-089, Hardware /Software System Configurations - 2047314-017, Hardware /Software System Configurations - 2047314-092, Hardware /Software System Configurations - 2047314-018, Hardware /Software System Configurations - 2047314-093, Hardware /Software System Configurations - 2047314-020, Hardware /Software System Configurations - 2047314-094, Hardware /Software System Configurations - 2047314-015, Software Only System Configurations - 2047314-021, Software Only System Configurations - 2047314-101, Software Only System Configurations - 2047314-022, Software Only System Configurations - 2047314-104, Software Only System Configurations - 2047314-023, Software Only System Configurations - 2047314-105, Software Only System Configurations - 2047314-025, Software Only System Configurations - 2047314-026, Software Only System Configurations - 2047314-099, ENGLISH LANGUAGE SELECTION - 2027879-034, ENGLISH LANGUAGE SELECTION - 2027879-036, ENGLISH LANGUAGE SELECTION - 2027879-178, SOFTWARE OPTIONS - 2047314-056, SOFTWARE OPTIONS - 2047314-057, SOFTWARE OPTIONS - 2047314-058, SOFTWARE OPTIONS - 2047314-059, SOFTWARE OPTIONS - 2047314-060, SOFTWARE OPTIONS - 2047314-061, SOFTWARE OPTIONS - 2047314-106, CARD READER - 2047314-063, CARD READER - 2027495-004, CARD READER - 2047314-064, CARD READER - 422187-001, CONNECTIVITY - 2047314-065, CONNECTIVITY - 2047314-066, CONNECTIVITY - 2047314-067, Power Conditioner - 2047314-111, Power Conditioner - 2047314-112, MODEM - 2047314-107, MODEM - 2003096-001, MODEM - 2047314-108, MODEM - 2003096-002, MARS V8 SP4 - 2082218-001, Upgrade: MARS V8 SP4 - 2082669-023
Authorization number:
DE0014975
Authorization date:
2014-03-20

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