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.
Clearance details
- Applicant
- Intelligent Hearing Systems
- Product code
- Code GWJ
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.