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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 the device name listed in this FDA 510(k) record. The listed applicant is Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) 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. The listed applicant is Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. The 510(k) number is K233001.

When did Bioscope Neuromonitor Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Bioscope Neuromonitor Device?

The FDA 510(k) record lists Biosys Biyomedikal Muhendislik San. VE Tic. A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioscope Neuromonitor Device?

The FDA product code for Bioscope Neuromonitor Device is ETN.

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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.

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