Clearance Summary
ALGO Pro Newborn Hearing Screener (ALGO Pro) received FDA 510(k) clearance under submission number K233649, sponsored by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-03-08.
- Submission: K233649
- Applicant / Sponsor: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 2024-03-08
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.