EarliPoint— 510(k) K230337
Substantially EquivalentEarlitec Diagnostics, Inc.
FDA 510(k) clearance K230337 for EarliPoint, Substantially Equivalent on 2023-06-29. Applicant: Earlitec Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Earlitec Diagnostics, Inc.
- 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
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code QPF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.