510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001347Substantially Equivalent

Meridian-II and Merdian-Plus

Meridian AG, Songpa-Gu, Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001347 is the FDA 510(k) clearance record for MERIDIAN-II AND MERDIAN-PLUS, a class II device, cleared for Meridian Co., Ltd. on under FDA product code GZO (Device, Galvanic Skin Response Measurement). FDA records list 13 510(k) clearances for Meridian Co., Ltd., from to . As of , FDA records show no recalls naming K001347.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GZO Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Applicant
Meridian Co., Ltd. 9fi Seoil Bldg, Songpa-Gu, Seoul, KR
510(k) summary
Summary
Third party review
No

Clearances, product code GZO

Trailing 12 months

FDA records hold no clearances under product code GZO in the trailing twelve months.

FDA records show no clearances under product code GZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260