MERIDIAN-II AND MERDIAN-PLUS— 510(k) K001347

Name: FDA 510(k) clearance K001347
Creator: U.S. Food and Drug Administration
Published: 2000-11-03

Substantially Equivalent

Meridian Co., Ltd.

FDA 510(k) clearance K001347 for MERIDIAN-II AND MERDIAN-PLUS, Substantially Equivalent on 2000-11-03. Applicant: Meridian Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meridian Co., Ltd.
Product code: Code GZO
Device class: Class 2
Regulation: 21 CFR 882.1540
Advisory panel: Neurology
Date received: 2000-04-28
Decision date: 2000-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Songpa-Gu, Seoul, KR

Download summary PDF View on FDA.gov ↗

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