micromed

MICROMED SPA · Model BRAIN QUICK · UDI-DI 08033928120910

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals.

Recalls

Date	Firm	Reason
2018-02-01	Natus Neurology Inc	Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

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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.