SmartEP— 510(k) K163326
Substantially EquivalentIntelligent Hearing Systems
FDA 510(k) clearance K163326 for SmartEP, Substantially Equivalent on 2017-09-29. 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.