# K971828: Alexander Manufacturing CO. Rechargeable Battery Part Number GL0810-0115

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: Aug 12, 1997 after 88 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822909 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822909: Pulse Oximeter Model 100, Nellcor, Inc. (1982) Summary page 3.

## Indications for use
Replacement battery for Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter, 510(k) Number K822909. 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/K971828
Methodology: https://510kreport.com/methodology