K233649
- 510(k) number
- K233649
- Device name
- ALGO Pro Newborn Hearing Screener (ALGO Pro)
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) CA
- Product code
- GWJ — Stimulator, Auditory, Evoked Response
- Decision date
- 2024-03-08
- Date received
- 2023-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K233649.pdf
Official FDA record: K233649
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.