Delphi-MD System
FDA 510(k) clearance DEN250002 · decided 2025-08-20
Clearance details
- K-number
- DEN250002
- Device name
- Delphi-MD System
- Applicant
- Quantalx Neuroscience, Ltd.
- Decision
- Unknown
- Date received
- 2025-01-03
- Decision date
- 2025-08-20
- Days to decision
- 229 days
- Clearance type
- Direct
- Product code
- SFN
- Device class
- 2
- Regulation number
- 882.1860
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kfar-Saba, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.