# K003154: Mizar, Basis BE, Sandman Digital

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Jan 5, 2001 after 87 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
No predicates in its family tree.
116 later devices descend from it; 5 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031202: Medipalm-20 (2003), 48 descendants of its own
- K071230: Apnea Risk Evaluation System (Ares), Model 600 (2007), 43 descendants of its own
- K110705: Apnea Risk Evaluation System (Ares) (2011), 41 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own

Source page: https://510kreport.com/device/K003154
Methodology: https://510kreport.com/methodology