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Nurochek-Pro Saline Solution

HEADSAFE MFG PTY LTD · Model Saline Solution Bottle Assembly (HS03-368) · UDI-DI 09357225006029

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

Description

The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The solution is used to support electrical contact between the Nurochek-Pro headset sensors and the skin during device operation. The saline solution has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The product is supplied 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.