510(k) K070608— SMARTEP, MODEL M010000
Substantially EquivalentIntelligent 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.