# K040113: Sandman SD20 Amplifier

- Pathway: 510(k) (Special)
- Applicant: Eb Neuro S.P.A.
- Decided: Feb 18, 2004 after 29 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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 K003154 (2001). 1 ancestor in all.
16 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003154: Mizar, Basis BE, Sandman Digital, Eb Neuro S.P.A. (2001) Summary page 1.

## Most influential descendants
- K090957: Blackrock Neuroport Biopotential Signal Processing System (2009), 13 descendants of its own
- K103140: Nicolet Wireless Eeg (2011), 7 descendants of its own
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own
- K170441: ElectroTek (2017), 1 descendant of its own
- K162681: Enobio Wireless EEG (2017), 1 descendant of its own

## Indications for use
The SD20 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

Source page: https://510kreport.com/device/K040113
Methodology: https://510kreport.com/methodology