510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163270Substantially Equivalent

ISEN-Goggles with Data Viewer

Isent Tech & Trading Company, Ltd., Beijing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163270 is the FDA 510(k) clearance record for ISEN-Goggles with Data Viewer, a class II device, cleared for Isent Tech & Trading Company, Ltd. on under FDA product code GWN (Nystagmograph). FDA records list one 510(k) clearance for Isent Tech & Trading Company, Ltd. As of , FDA records show no recalls naming K163270.

Clearance record

Decision date
Received
(308 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Isent Tech & Trading Company, Ltd. Rm509, Bldg. A, Cybertower, #2 Zhongguancun S Ave., Beijing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWN

Trailing 12 months
1 clearance under product code GWN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260