# K991012: Siemens Infinity Eeg Pod

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 24, 1999 after 90 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K963644 (1996). 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)
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor, Aspect Medical Systems, Inc. (1996) Summary page 1.

## Indications for use
Siemens INFINITY EEG Pod is indicated for use in the adult, pediatric and nreonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the state of the brain by data acquisition of EEG signals.

Source page: https://510kreport.com/device/K991012
Methodology: https://510kreport.com/methodology