# K971740: Amplaid MK12

- Pathway: 510(k) (Traditional)
- Applicant: Amplifon S.P.A.
- Decided: Mar 16, 1998 after 308 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 K861014 (1986). 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)
- K861014: Amplaid MK15 (Evoked Potential System), Amplaid USA, Inc. (1986) Summary page 1.

## Indications for use
The Amplaid MK 12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including: 1. Electronystagmography 2. Visual evoked potentials, 3. Auditory evoked potentials, and 4. Electrical (somatosensory) evoked potentials.

Source page: https://510kreport.com/device/K971740
Methodology: https://510kreport.com/methodology