EarliPoint System— 510(k) K243891
Substantially EquivalentEarlitec Diagnostics
FDA 510(k) clearance K243891 for EarliPoint System, Substantially Equivalent on 2025-03-26. Applicant: Earlitec Diagnostics. Device class: 2.
Clearance details
- Applicant
- Earlitec Diagnostics
- Product code
- Code QPF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1491
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
Recent devices under product code QPF
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