# K991735: Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Aug 19, 1999 after 90 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921669 (1993). 4 ancestors in all.
81 later devices descend from it; 3 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820885: Marquette Option II Ecg Analysis Comput, Marquette Electronics, Inc. (1982) Summary page 1.
- K964750: Eagle 4000 Patient Monitor, Marquette Electronics, Inc. (1997) Summary page 1.

## Most influential descendants
- K014108: Mac 5000 Ecg Analysis System (2002), 71 descendants of its own
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), 32 descendants of its own
- K033492: Modification to Mac 5000 Ecg Analysis System (2003), 31 descendants of its own
- K042177: Modification to Mac 5000 Ecg Analysis System (2004), 30 descendants of its own
- K060833: 12SL Ecg Analysis Program (2006), 21 descendants of its own

## Indications for use
The MAC Series Resting ECG Analysis Systems (Includes the MAC PC, MAC 6, MAC VU, MAC 8, and MAC 5000) are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG’s, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC Series is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Source page: https://510kreport.com/device/K991735
Methodology: https://510kreport.com/methodology