# K012264: Marquette MAC8, Mac Personal, Mac Stress, Model N3043IWC

- Pathway: 510(k) (Traditional)
- Applicant: National Custom Ent., Inc.
- Decided: Oct 10, 2001 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Source page: https://510kreport.com/device/K012264
Methodology: https://510kreport.com/methodology