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Nurochek-Pro Soft Sensor Kit

HEADSAFE MFG PTY LTD · Model Nurochek-Pro Soft Sensor Kit (HS03-313) · UDI-DI 09357225003028

PIWOMC
1
510(k) clearances
0
Adverse events
0
Recalls
3
Facilities

Description

The Nurochek-Pro Soft Sensor Kit is a non-invasive accessory intended for use with the Nurochek-Pro headset. The kit contains soft sensor components designed to interface with the Nurochek-Pro headset to support EEG acquisition. The Soft Sensor Kit has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The accessory is supplied non-sterile and is intended for use by healthcare professionals in accordance with the Nurochek-Pro system Instructions for Use

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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.