ISEN-Goggles— 510(k) K152727

Substantially Equivalent

Isen Tech & Trading Company, Ltd.

FDA 510(k) clearance K152727 for ISEN-Goggles, Substantially Equivalent on 2016-04-26. Applicant: Isen Tech & Trading Company, Ltd.. Device class: 2.

Clearance details

Applicant: Isen Tech & Trading Company, Ltd.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2015-09-22
Decision date: 2016-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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