FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
Bioscope Neuromonitor Device
K Number: K233001
·
Decision Dec 13, 2024
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
94
Applicant Total
1
Review Days
448
Basic Information
- Device Name
- Bioscope Neuromonitor Device
- K Number
- K233001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosys Biyomedikal Muhendislik San. Ve Tic. A.S.
- Date Received
- September 22, 2023
- Decision Date
- December 13, 2024
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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