NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

Electrode, Needle, Diagnostic Electromyograph

DANTEC MEDICAL, INC.

The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Needle Electrodes And Disposable Scalp Electrode.

Pre-market Notification Details

• Device ID: K932059
• 510k Number: K932059
• Device Name: NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
• Classification: Electrode, Needle, Diagnostic Electromyograph
• Applicant: DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005
• Contact: Richard D Manthei
• Correspondent: Richard D Manthei; DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005
• Product Code: IKT
• CFR Regulation Number: 890.1385 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-29
• Decision Date: 1994-10-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05704736002158	K932059	000
05704736002035	K932059	000