Focus

NEUROSOFT, OOO · Model Focus · UDI-DI 04650075330074

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510(k) clearances

Adverse events

Recalls

Facilities

Description

2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.

Recalls

Date	Firm	Reason
2012-04-18	Biomet, Inc.	Incorrect product picture label was on the product box.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.