Dantec 13R45 Bar Electrode

FDA 510(k) K934580 · Dantec Medical, Inc.

Substantially Equivalent

510(k) numberK934580

Submission

Device name
Dantec 13R45 Bar Electrode
Applicant
Dantec Medical, Inc.
Washington, DC, US
Received
September 23, 1993
Decision date
September 26, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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More from Bionit Labs Srl

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K960503Dantec DuetFEN · Traditional 09/16/1996SE
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K953999Dantec Da CapoEXY · Traditional 11/21/1995SE
K926363Multi-Dop SIYO · Traditional 06/19/1995SE
K931801Multi-Dop XIYO · Traditional 06/14/1995SE
K930458Multi-Dop LIYN · Traditional 02/03/1995SE
K932059Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional 10/04/1994SE
K931966Dantec Disposable Concentric NeedleIKT · Traditional 03/30/1994SE
K931923Dantec Maglite Magnetic Stimulator (Maglite)GWF · Traditional 11/09/1993SE
K926516Dantec Magnetic Stimulator MagproGWF · Traditional 08/31/1993SE

Questions and answers

When was Dantec 13R45 Bar Electrode cleared by the FDA?

Dantec 13R45 Bar Electrode (K934580) received a 510(k) decision of Substantially Equivalent on September 26, 1994, 368 days after the submission was received.

What is the product code of K934580?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.