EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG

Electrode, Cutaneous

NICOLET BIOMEDICAL INSTRUMENTS

The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Emg Surface, Digital Ring, Bar, Grounding, Eeg.

Pre-market Notification Details

• Device ID: K850108
• 510k Number: K850108
• Device Name: EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
• Classification: Electrode, Cutaneous
• Applicant: NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711
• Contact: Ron Luich
• Correspondent: Ron Luich; NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-01-10
• Decision Date: 1985-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00382830040235	K850108	000
00382830040228	K850108	000
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00613994870919	K850108	000
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00382830040549	K850108	000