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encevis 2.1/2.2

by AIT Austrian Institute of Technology GmbH

encevis 2.1/2.2 is a Class II device made by AIT Austrian Institute of Technology GmbH, cleared under FDA 510(k) K240993 on 27 Sep 2024 and listed in FDA GUDID since 5 Aug 2025 (UDI-DI 09120109830269), 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) K240993

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 Number09120109830269 UDI-DI Date5 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240993 Date27 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240993 decided 27 Sep 2024 Active
  • FDA GUDID UDI-DI 09120109830269 listed 5 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240993
  2. Listed FDA GUDID 09120109830269

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
encevis
Generic name
Bioelectrical signal analysis software
Model / reference
2.1/2.2
Primary DI / UDI-DI
09120109830269
510(k) Number
FDA product code
OMB, OLT, OMA
GMDN term
Bioelectrical signal analysis software
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bioelectrical signal analysis software

Similar devices

Other devices filed under FDA product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph).

Other devices from AIT Austrian Institute of Technology GmbH

  • encevis 1.6

    Class II

  • encevis 1.12

    Class II

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)