FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Axonpen, Axonmonitor, Axonbox, Tablet
K Number: K201308
·
Decision Nov 27, 2020
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
3
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Axonpen, Axonmonitor, Axonbox, Tablet
- K Number
- K201308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clearmind Biomedical
- Date Received
- May 15, 2020
- Decision Date
- November 27, 2020
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWG), ordered by most recent decision date.
Precision S 4K Sinuscope
FDA 510(k)
FDA Class 2
·Neurology
Hydro Irrigation System
FDA 510(k)
FDA Class 2
·Neurology
HJY VisualNext 3D Endoscopic Vision System
FDA 510(k)
FDA Class 2
·Neurology
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
FDA 510(k)
FDA Class 2
·Neurology
cCeLL - In vivo
FDA 510(k)
FDA Class 2
·Neurology
Digital ClarusScope System, Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Neurology