# K011746: MB 11

- Pathway: 510(k) (Traditional)
- Applicant: Maico Diagnostic GmbH
- Decided: Aug 24, 2001 after 79 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) — based measurements for both child and newborn hearing screening..

Source page: https://510kreport.com/device/K011746
Methodology: https://510kreport.com/methodology