INF 4160, MODEL D-FJ27F— 510(k) K043407

Substantially Equivalent

Fuji Dynamics Limited

FDA 510(k) clearance K043407 for INF 4160, MODEL D-FJ27F, Substantially Equivalent on 2005-02-11. 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: 2004-12-10
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dong Guan, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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