# K103765: Mac 600 Resting Ecg Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: May 17, 2011 after 145 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 1.

## Indications for use
The MAC 600 Resting EGG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems deliver 3 or 12 lead EGGs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. Transmission of EGG data to a central EGG cardiovascular information system is optional. The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever EGG testing is performed to record EGG signals from surface electrodes. Contra-indications 1. MAC 600 is not intended for use as a vital signs physiological monitor. 2. MAC 600 is not intended for use during patient transport. 3. MAC 600 is not intended for intra cardiac application. 4. MAC 600 is not intended for use with high frequency surgical units.

Source page: https://510kreport.com/device/K103765
Methodology: https://510kreport.com/methodology