FDA AI Clearance Tracker/K250818

Anesthesiology · 510(k)

Nerveblox

Smart Alfa Teknoloji San. Ve Tic. A.S.

About this listing

Nerveblox from Smart Alfa Teknoloji San. Ve Tic. A.S. appears on the U.S. FDA list of AI-enabled medical devices under submission K250818. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated August 15, 2025. Its primary FDA product code is QRG.

The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.

Device
Nerveblox
Company
Smart Alfa Teknoloji San. Ve Tic. A.S.
Submission number
K250818
Pathway
510(k)
Decision date
Aug 15, 2025
Specialty (lead panel)
Anesthesiology
Primary product code
QRG

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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.