WAVE 2G, SOUL— 510(k) K130937
Substantially EquivalentHansaton Akustik GmbH
FDA 510(k) clearance K130937 for WAVE 2G, SOUL, Substantially Equivalent on 2014-01-03. Applicant: Hansaton Akustik GmbH. Device class: 2.
Clearance details
- Applicant
- Hansaton Akustik GmbH
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Recent devices under product code KLW
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