FD TENS 2070— 510(k) K111654

Clearance details

Applicant

Fuji Dynamics , Ltd.

Product code

Code GZJ

Device class

Class 2

Regulation

21 CFR 882.5890

Advisory panel

Neurology

Date received

2011-06-13

Decision date

2012-03-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hong Kong, CN

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