# K083371: Navigator Pro with Aep Software (Biomark, Enog, Champ)

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Dec 8, 2009 after 389 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: 5 generations back to K930328 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073626: Bio-Logic Master II Evoked Response System, Bio-Logic Systems Corp. (2008) Summary page 1.
- K031009: Modification to Bio-Logic Evoked Potential (EP) System, Bio-Logic Systems Corp. (2003) Summary page 1.
- K030907: Stacked Abr for Navigator Pro, Bio-Logic Systems Corp. (2003) Summary page 1.
- K070608: Smartep, Model M010000, Intelligent Hearing Systems (2007) Summary page 1.
- K844992: Bio-Logic Portable Evoked Response System, Bio-Logic Systems Corp. (1985) Summary page 1.

## Indications for use
The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

Source page: https://510kreport.com/device/K083371
Methodology: https://510kreport.com/methodology