# K962457: Two-Channel Preamplifier

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Laboratories, Inc.
- Decided: Jan 13, 1997 after 202 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 K924723 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924723: Cadwell Sierra, Cadwell Laboratories, Inc. (1993) Summary page 1.
- K931428: Cadwell 6200 a, Cadwell Laboratories, Inc. (1993) Summary page 1.

## Indications for use
The general purpose of the proposed device is identical to the predicate device: "to rm the measurements needed for electromyography G), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The proposed device allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.

Source page: https://510kreport.com/device/K962457
Methodology: https://510kreport.com/methodology