COMBY EEG CAP Chest belt for EEG cap for adults, L

• FDA 510(k) K211315 decided 9 Nov 2021 Active
• FDA GUDID UDI-DI 03858894154500 listed 28 Feb 2025 Listed

1. 9 Nov 2021 Cleared FDA 510(k) K211315
2. 28 Feb 2025 Listed FDA GUDID 03858894154500

Trade name

Comby EEG Cap

Generic name

Analytical scalp electrode, reusable

Model / Ref / Catalog

Chest belt for EEG cap for adults, L, BFRA_L

Primary DI / UDI-DI

03858894154500

510(k) Number

K211315 ↗

FDA product code

GXY

GMDN term

Analytical scalp electrode, reusable

Device class

Class II

Regulation number

882.1320

GUDID distribution status

In Commercial Distribution

Category: Analytical scalp electrode, reusable

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

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• BRAINET by Nicolet Biomedical, Inc.
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• PRO-CHILL STIMPACK by Tko, Inc.
• ELECTRO-MESH GLOVE by Whiting & Davis Co.
• STATNET, MODEL 3100 by Hydrodot, Inc.
• MR Conditional Cup Electrode, MR Conditional Webb Electrode by Rhythmlink International, LLC
• INTERX500 FLEXIBLE ARRAY ELECTRODE by Neuro Resource Group, Inc.
• MODIFICATION TO:APEX MEDICAL IF-4100 by Apex Medical Corp.
• EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG by Nicolet Biomedical Instruments

• COMBY EEG CAP Chest belt for EEG cap for adults, S

  Class II

  FDA 510(k) K211315 Active Cleared 9 Nov 2021 GUDID on market

• COMBY EEG CAP Chest belt for EEG cap for adults

  Class II

  FDA 510(k) K211315 Active Cleared 9 Nov 2021 GUDID on market

• COMBY EEG CAP Chest belt for EEG cap for adults, M

  Class II

  FDA 510(k) K211315 Active Cleared 9 Nov 2021 GUDID on market

• Comby EEG Cap/ 34 Ag/AgCl EL.

  Class II

  FDA 510(k) K211315 Active Cleared 9 Nov 2021 GUDID on market

See all devices from PAMEL d.o.o. →