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510(k) K233001

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
September 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

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