# K172892: Neuro Assessment System NAS-1000

- Pathway: 510(k) (Traditional)
- Applicant: Headsense Medical, Inc.
- Decided: Mar 8, 2018 after 167 days
- Product code: QBE (Cranial Sound Monitor)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771653 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 5.

## Indications for use
The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

Source page: https://510kreport.com/device/K172892
Methodology: https://510kreport.com/methodology