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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K233001
Device Name Bioscope Neuromonitor Device
Applicant
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Bul. Cd. Sk. No:23/C
Ankara,  TR 06800
Applicant Contact Cemal Erdogan
Correspondent
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Bul. Cd. Sk. No:23/C
Ankara,  TR 06800
Correspondent Contact Cemal Erdogan
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/22/2023
Decision Date 12/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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