DIXI Medical Microdeep Micro-Macro Depth Electrodes
FDA 510(k) clearance K202087 · decided 2021-11-18
Clearance details
- K-number
- K202087
- Device name
- DIXI Medical Microdeep Micro-Macro Depth Electrodes
- Applicant
- Dixi Medical
- Decision
- Substantially Equivalent
- Date received
- 2020-07-28
- Decision date
- 2021-11-18
- Days to decision
- 478 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chaudefontaine, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.