cCeLL - In vivo
FDA 510(k) clearance K233391 · decided 2024-08-21
Clearance details
- K-number
- K233391
- Device name
- cCeLL - In vivo
- Applicant
- VPIX Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-02
- Decision date
- 2024-08-21
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- GWG
- Device class
- 2
- Regulation number
- 882.1480
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Daejeon, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.