ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE— 510(k) K040639

Name: FDA 510(k) clearance K040639
Creator: U.S. Food and Drug Administration
Published: 2004-05-21

Substantially Equivalent

Isurgical

FDA 510(k) clearance K040639 for ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, Substantially Equivalent on 2004-05-21. Applicant: Isurgical. Device class: 2.

Clearance details

Applicant: Isurgical
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2004-03-10
Decision date: 2004-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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