GWJ
- Product code
- GWJ
- Device name
- Stimulator, Auditory, Evoked Response
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1900
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 76 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242954 | 2024-12-19 | Vivosonic, Inc. | Integrity V500 (Integrity, Integrity with VEMP) | |
| K233649 | 2024-03-08 | Natus Medical Incorporated Dba Excel-T… | ALGO Pro Newborn Hearing Screener (ALGO Pro) | FDA |
Official FDA classification page: GWJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).