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NeuroMatch 1.0.7

by LVIS Corporation

NeuroMatch 1.0.7 is a Class II device made by LVIS Corporation, cleared under FDA 510(k) K250239 on 23 May 2025 (2 earlier submissions) and listed in FDA GUDID since 12 May 2026 (UDI-DI 00850056774017), active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850056774017 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250239 Date23 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250239 decided 23 May 2025 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00850056774017 listed 12 May 2026 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K222450
  2. Cleared FDA 510(k) K241390
  3. Cleared FDA 510(k) K250239
  4. Listed FDA GUDID 00850056774017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeuroMatch
Generic name
Electroencephalographic diagnosis-support software
Model / reference
1.0.7
Primary DI / UDI-DI
00850056774017
510(k) Number
FDA product code
OMB, OLT, OMA, OLX
GMDN term
Electroencephalographic diagnosis-support software
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from LVIS Corporation

Properties

  • Prescription use
Other properties (14, all answered No)