DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431

Electrode, Needle, Diagnostic Electromyograph

MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Disposable Hypodermic Needle Electrode, Model 9013s0421,9013s0431,9013s0441,9013s0451,9013s0461,1013s0421,103s0431.

Pre-market Notification Details

• Device ID: K002992
• 510k Number: K002992
• Device Name: DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
• Classification: Electrode, Needle, Diagnostic Electromyograph
• Applicant: MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740
• Contact: Tove Kjaer
• Correspondent: Tove Kjaer; MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740
• Product Code: IKT
• Subsequent Product Code: FMI
• Subsequent Product Code: GXZ
• CFR Regulation Number: 890.1385 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-25
• Decision Date: 2001-08-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169938687	K002992	000
00763000034047	K002992	000
20763000038285	K002992	000
20763000038292	K002992	000
20763000038308	K002992	000
00643169290006	K002992	000
00643169290013	K002992	000
20643169294367	K002992	000
20643169294374	K002992	000
20643169294381	K002992	000
00643169694996	K002992	000
00643169695009	K002992	000
20643169938636	K002992	000
20643169938643	K002992	000
20643169938667	K002992	000
00643169938670	K002992	000
00763000034030	K002992	000