Delphi MCS Electrode Cap— 510(k) K243243
Substantially EquivalentQuantalx Neuroscience, Ltd.
FDA 510(k) clearance K243243 for Delphi MCS Electrode Cap, Substantially Equivalent on 2025-02-06. Applicant: Quantalx Neuroscience, Ltd.. Device class: 2.
Clearance details
- Applicant
- Quantalx Neuroscience, Ltd.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kfar Sava, IL
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