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LVIS NeuroMatch

by LVIS Corporation

510(k) K222450

LVIS NeuroMatch is a Class II device made by LVIS Corporation, cleared under FDA 510(k) K222450 on 9 Jun 2023, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222450 Date9 Jun 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OMB
Device class
Class II
Regulation
21 CFR Part 882.1400
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K222450

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222450
UDI-DISize and differences
NeuroMatch 1.0.7
LVIS Corporation
1.0.700850056774017 —On the market

Similar devices

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

Other devices from LVIS Corporation