SMARTEP-ASSR, MODEL M811007— 510(k) K031051
Substantially EquivalentIntelligent Hearing Systems
FDA 510(k) clearance K031051 for SMARTEP-ASSR, MODEL M811007, Substantially Equivalent on 2004-02-20. Applicant: Intelligent Hearing Systems. Device class: 2.
Clearance details
- Applicant
- Intelligent Hearing Systems
- 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
- Miami, FL, US
Recent devices under product code GWJ
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