Bioscope Neuromonitor Device— 510(k) K233001
Substantially EquivalentBiosys Biyomedikal Muhendislik San. VE Tic. A.S.
FDA 510(k) clearance K233001 for Bioscope Neuromonitor Device, Substantially Equivalent on 2024-12-13. Applicant: Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. Device class: 2.
Clearance details
- Applicant
- Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ankara, TR
Recent devices under product code ETN
view all- K253536 — Evala Nerve Stimulator (EPNR002)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
- K241917 — EARP Nerve Cuff Electrode
- K232888 — Disposable Laryngeal Electrodes
Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.