FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EEG WITH VIDEO, MODEL EX-NW
K Number: K010091
·
Decision Feb 1, 2001
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
58
Review Days
21
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Basic Information
- Device Name
- EEG WITH VIDEO, MODEL EX-NW
- K Number
- K010091
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Excel Tech. , Ltd.
- Date Received
- January 11, 2001
- Decision Date
- February 1, 2001
- 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 |
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