ALGO 5 NEWBORN HEARING SCREENER— 510(k) K073665
Substantially EquivalentNatus Medical, Inc.
FDA 510(k) clearance K073665 for ALGO 5 NEWBORN HEARING SCREENER, Substantially Equivalent on 2008-01-25. Applicant: Natus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Natus Medical, Inc.
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Carlos, CA, US
Recent devices under product code GWJ
view allMore clearances from Natus Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.