EarliPoint— 510(k) K230337

Substantially Equivalent

Earlitec Diagnostics, Inc.

FDA 510(k) clearance K230337 for EarliPoint, Substantially Equivalent on 2023-06-29. Applicant: Earlitec Diagnostics, Inc..

Clearance details

Applicant
Earlitec Diagnostics, Inc.
Product code
Code QPF
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Atlanta, GA, US
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