DISPOSABLE ADHESIVE SURFACE ELECTRODE— 510(k) K120494

Name: FDA 510(k) clearance K120494
Creator: U.S. Food and Drug Administration
Published: 2012-06-11

Substantially Equivalent

Spes Medica Srl

FDA 510(k) clearance K120494 for DISPOSABLE ADHESIVE SURFACE ELECTRODE, Substantially Equivalent on 2012-06-11. Applicant: Spes Medica Srl. Device class: 2.

Clearance details

Applicant: Spes Medica Srl
Product code: Code GXY
Device class: Class 2
Regulation: 21 CFR 882.1320
Advisory panel: Neurology
Date received: 2012-02-17
Decision date: 2012-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battipaglia, IT

Download summary PDF View on FDA.gov ↗

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