ALGO 3 NEWBORN HEARING SCREENER— 510(k) K013137
Substantially EquivalentNatus Medical, Inc.
FDA 510(k) clearance K013137 for ALGO 3 NEWBORN HEARING SCREENER, Substantially Equivalent on 2001-10-16. 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
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