WAVE 2G, SOUL— 510(k) K130937

Substantially Equivalent

Hansaton Akustik GmbH

FDA 510(k) clearance K130937 for WAVE 2G, SOUL, Substantially Equivalent on 2014-01-03. Applicant: Hansaton Akustik GmbH.

Clearance details

Applicant: Hansaton Akustik GmbH
Product code: Code KLW
Advisory panel: Ear, Nose, Throat
Date received: 2013-04-04
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.