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

by PAMEL d.o.o.

COMBY EEG CAP Chest belt for EEG cap for adults, M (BFRA_M) is a Class II device made by PAMEL d.o.o., cleared under FDA 510(k) K211315 on 9 Nov 2021 and listed in FDA GUDID since 28 Feb 2025 (UDI-DI 03858894154517), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K211315

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03858894154517 UDI-DI Date28 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211315 Date9 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211315 decided 9 Nov 2021 Active
  • FDA GUDID UDI-DI 03858894154517 listed 28 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211315
  2. Listed FDA GUDID 03858894154517

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comby EEG Cap
Generic name
Analytical scalp electrode, reusable
Model / Ref / Catalog
Chest belt for EEG cap for adults, M, BFRA_M
Primary DI / UDI-DI
03858894154517
510(k) Number
FDA product code
GXY
GMDN term
Analytical scalp electrode, reusable
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Analytical scalp electrode, reusable

Cleared under the same submission (K211315)

and 5 more cleared under K211315

Similar devices

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

Other devices from PAMEL d.o.o.

See all devices from PAMEL d.o.o. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)