EarliPoint System— 510(k) K243891

Substantially Equivalent

Earlitec Diagnostics

FDA 510(k) clearance K243891 for EarliPoint System, Substantially Equivalent on 2025-03-26. Applicant: Earlitec Diagnostics.

Clearance details

Applicant
Earlitec Diagnostics
Product code
Code QPF
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.