REVE134— 510(k) K151719

Substantially Equivalent

Kw Ear Lab, Inc.

FDA 510(k) clearance K151719 for REVE134, Substantially Equivalent on 2015-10-09. Applicant: Kw Ear Lab, Inc..

Clearance details

Applicant: Kw Ear Lab, Inc.
Product code: Code KLW
Advisory panel: Ear, Nose, Throat
Date received: 2015-06-25
Decision date: 2015-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson, CA, US

Download summary PDF View on FDA.gov ↗

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