DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)— 510(k) K950314

Name: FDA 510(k) clearance K950314
Creator: U.S. Food and Drug Administration
Published: 1996-03-25

Substantially Equivalent

Dantec Medical, Inc.

FDA 510(k) clearance K950314 for DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19), Substantially Equivalent on 1996-03-25. Applicant: Dantec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dantec Medical, Inc.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 1995-01-26
Decision date: 1996-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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