FDA 510(k)

Bioscope Neuromonitor Device

K-Number: K233001 · 2024-12-13

ApplicantBiosys Biyomedikal Muhendislik San. VE Tic. A.S.

Decision Date2024-12-13

Product CodeETN

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Bioscope Neuromonitor Device is a medical device manufactured by Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. It received FDA 510(k) clearance on 2024-12-13 under approval number K233001. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bioscope Neuromonitor Device?

Bioscope Neuromonitor Device is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. The 510(k) number is K233001.

When was Bioscope Neuromonitor Device approved by the FDA?

Bioscope Neuromonitor Device received FDA 510(k) clearance on 2024-12-13, under approval number K233001.

What company makes Bioscope Neuromonitor Device?

Bioscope Neuromonitor Device is manufactured by Biosys Biyomedikal Muhendislik San. VE Tic. A.S..

What is the FDA product code for Bioscope Neuromonitor Device?

The FDA product code for Bioscope Neuromonitor Device is ETN.

Related Devices (Code: ETN)

K152769FREMAP ELECTRODEAd-Tech Medical Instrument Corporation K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH K200886StimSiteAllotrope Medical, Inc. K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical K212164Mapping Suction ProbeInomed Medizintechnik GmbH K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.