510(k) K233001

Bioscope Neuromonitor Device by Biosys Biyomedikal Muhendislik San. VE Tic. A.S. — Product Code ETN

K233001 is an FDA 510(k) premarket notification submitted by Biosys Biyomedikal Muhendislik San. VE Tic. A.S. for the device "Bioscope Neuromonitor Device". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820.