Eclipse with VEMP— 510(k) K162037

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K162037 for Eclipse with VEMP, Substantially Equivalent on 2017-03-23. Applicant: Interacoustics A/S.

Clearance details

Applicant: Interacoustics A/S
Product code: Code GWJ
Advisory panel: Neurology
Date received: 2016-07-22
Decision date: 2017-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middelfart, DK

Download summary PDF View on FDA.gov ↗

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