DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Electrode, Needle, Diagnostic Electromyograph

CHALGREN ENTERPRISES, INC.

The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Detachable, Disposable Monopolar Needle Electrode.

Pre-market Notification Details

• Device ID: K912283
• 510k Number: K912283
• Device Name: DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
• Classification: Electrode, Needle, Diagnostic Electromyograph
• Applicant: CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020
• Contact: Richard Kaiser
• Correspondent: Richard Kaiser; CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020
• Product Code: IKT
• CFR Regulation Number: 890.1385 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-05-23
• Decision Date: 1992-03-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816020020061	K912283	000
00816020020054	K912283	000
00816020020047	K912283	000
00816020020030	K912283	000
00816020020016	K912283	000
00816020020009	K912283	000