SMART COUPLER, MODEL M015401— 510(k) K073384
Substantially EquivalentIntelligent Hearing Systems
FDA 510(k) clearance K073384 for SMART COUPLER, MODEL M015401, Substantially Equivalent on 2008-02-28. 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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