ELEFIX ELECTRODE CREAM— 510(k) K860210

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K860210 for ELEFIX ELECTRODE CREAM, Substantially Equivalent on 1986-07-01. Applicant: Nihon Kohden America, Inc.. Device class: 2.

Clearance details

Applicant
Nihon Kohden America, Inc.
Product code
Code GYB
Device class
Class 2
Regulation
21 CFR 882.1275
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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