ALGO Pro Newborn Hearing Screener (ALGO Pro)— 510(k) K233649
Substantially EquivalentNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
FDA 510(k) clearance K233649 for ALGO Pro Newborn Hearing Screener (ALGO Pro), Substantially Equivalent on 2024-03-08. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
Clearance details
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Product code
- Code GWJ
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakville, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.