# K090212: Mac 800 Resting Ecg Analysis System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Syst. Information Technologies
- Decided: Feb 19, 2009 after 22 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903644 (1991). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081437: Mac 1600 Ecg Analysis System, Ge Medical Systems Information Technologies (2008) Summary page 1.

## Most influential descendants
- K133622: Mac 2000 Ecg Analysis System (2014), 1 descendant of its own
- K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (2023), 0 descendants of its own
- K142288: MAC 800 Resting ECG Analysis System (2014), 0 descendants of its own
- K140020: Hyperq Acs-100 System (2014), 0 descendants of its own

## Recalls of this device
- Dec 10, 2009 · Not classified · Z-0645-2010: GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient

## Indications for use
The MAC 800 is a portable ECG acquisition, analysis and recording system. 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 MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. 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. The MAC 800 is used under the direct supervision of a licensed healthcare practitioner. Contraindications: The MAC 800 is not designed to provide alarms for arrhythmia detection. The device is not suitable for intra cardiac application. It is not intended for use: * As a vital signs physiological monitor; or * For use during patient transport.

Source page: https://510kreport.com/device/K090212
Methodology: https://510kreport.com/methodology