Cleared Traditional

Bioscope Neuromonitor Device

K233001 · Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · Ear, Nose, Throat
Dec 2024
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K233001 is an FDA 510(k) clearance for the Bioscope Neuromonitor Device, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Biosys Biyomedikal Muhendislik San. VE Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on December 13, 2024, 448 days after receiving the submission on September 22, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K233001 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date December 13, 2024
Days to Decision 448 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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