# K971099: Alexander Manufacturing CO. Rechargeable Battery Part Number MS5169

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: Jun 5, 1997 after 71 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- 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 for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A, 510(k) Number K831852. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor’s replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Source page: https://510kreport.com/device/K971099
Methodology: https://510kreport.com/methodology