INF 4160 PLUS, MODEL D-FJ31F— 510(k) K092780

Name: FDA 510(k) clearance K092780
Creator: U.S. Food and Drug Administration
Published: 2010-01-07

Substantially Equivalent

Fuji Dynamics Limited

FDA 510(k) clearance K092780 for INF 4160 PLUS, MODEL D-FJ31F, Substantially Equivalent on 2010-01-07. Applicant: Fuji Dynamics Limited. Device class: 2.

Clearance details

Applicant: Fuji Dynamics Limited
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2009-09-10
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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