510(k) K233649
K233649 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) for the device "ALGO Pro Newborn Hearing Screener (ALGO Pro)". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2024
- Date Received
- November 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type