Eclipse with VEMP— 510(k) K162037
Substantially EquivalentInteracoustics A/S
FDA 510(k) clearance K162037 for Eclipse with VEMP, Substantially Equivalent on 2017-03-23. Applicant: Interacoustics A/S. Device class: 2.
Clearance details
- Applicant
- Interacoustics A/S
- 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
- Middelfart, DK
Recent devices under product code GWJ
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