SYNAP-I INFANT SENSORY ASSESSMENT UNIT— 510(k) K810138
Substantially EquivalentInfant Hearing Assessment Foundation
FDA 510(k) clearance K810138 for SYNAP-I INFANT SENSORY ASSESSMENT UNIT, Substantially Equivalent on 1981-04-03. Applicant: Infant Hearing Assessment Foundation. Device class: 2.
Clearance details
- Applicant
- Infant Hearing Assessment Foundation
- 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
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GWJ
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