FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K Number: K062880
·
Decision Dec 22, 2006
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- SUBDERMAL WIRE ELECTRODE, MODEL SWE
- K Number
- K062880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ives Eeg Solutions, Inc.
- Date Received
- September 26, 2006
- Decision Date
- December 22, 2006
- Product Code
- GXZ
- 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 |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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