FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
DIXI Medical Microdeep Depth Electrode
K Number: K170959
·
Decision Nov 24, 2017
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
55
Applicant Total
1
Review Days
238
Basic Information
- Device Name
- DIXI Medical Microdeep Depth Electrode
- K Number
- K170959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIXI Medical
- Date Received
- March 31, 2017
- Decision Date
- November 24, 2017
- Product Code
- GZL
- 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 |
|---|---|---|---|
| GZL | Electrode, Depth | FDA class 2 | Neurology |
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