# K142288: MAC 800 Resting ECG Analysis System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Dec 3, 2014 after 107 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921669 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090212: Mac 800 Resting Ecg Analysis System, Ge Medical Syst. Information Technologies (2009) Summary page 4.
- K110132: Muse Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2011) Summary page 4.
- K060833: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2006) Summary page 4.

## Indications for use
The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics and physician offices outreach centers to record ECG signals from surface electrodes. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation.

Source page: https://510kreport.com/device/K142288
Methodology: https://510kreport.com/methodology