# K133622: Mac 2000 Ecg Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Wipro GE Healthcare
- Decided: Jan 23, 2014 after 62 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). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073625: Modification to: Mac 5500 Resting Ecg Analysis System, Ge Healthcare Systems Information Technologies (2008) Summary page 3.
- K090212: Mac 800 Resting Ecg Analysis System, Ge Medical Syst. Information Technologies (2009) Summary page 3.
- (no number) MAC 1600 ECG Analysis System: named in the summary without a submission number

## Most influential descendants
- K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (2023), 0 descendants of its own

## Indications for use
The MAC 2000 ECG analysis system is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician's office or outreach centers. NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years. The MAC 2000 ECG analysis system provides the following modes of operation: * Resting ECG mode * Arrhythmia mode * Exercise mode for exercise stress testing (optional) * RR analysis mode for RR interval analysis (optional) The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Arrhythmia detection is provided for the convenience of automatic documentation. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

Source page: https://510kreport.com/device/K133622
Methodology: https://510kreport.com/methodology