FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q21
K Number: K221959
·
Decision Aug 31, 2023
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
3
Review Days
422
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
- Q21
- K Number
- K221959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurofield, Inc.
- Date Received
- July 5, 2022
- Decision Date
- August 31, 2023
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWQ), ordered by most recent decision date.
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
FDA 510(k)
FDA Class 2
·Neurology
New Wave System
FDA 510(k)
FDA Class 2
·Neurology
Flexset System
FDA 510(k)
FDA Class 2
·Neurology
Neuronaute Plus
FDA 510(k)
FDA Class 2
·Neurology
SPARK Scan
FDA 510(k)
FDA Class 2
·Neurology
Cumulus Functional Neurophysiology Platform
FDA 510(k)
FDA Class 2
·Neurology