ISEN-Goggles with Data Viewer— 510(k) K163270

Name: FDA 510(k) clearance K163270
Creator: U.S. Food and Drug Administration
Published: 2017-09-25

Substantially Equivalent

Isent Tech & Trading Company, Ltd.

FDA 510(k) clearance K163270 for ISEN-Goggles with Data Viewer, Substantially Equivalent on 2017-09-25. Applicant: Isent Tech & Trading Company, Ltd.. Device class: 2.

Clearance details

Applicant: Isent Tech & Trading Company, Ltd.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2016-11-21
Decision date: 2017-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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