Smileyscope System (Therapy Mode)— 510(k) K230825

Substantially Equivalent

Smileyscope Holding, Inc.

FDA 510(k) clearance K230825 for Smileyscope System (Therapy Mode), Substantially Equivalent on 2023-09-25. Applicant: Smileyscope Holding, Inc..

Clearance details

Applicant: Smileyscope Holding, Inc.
Product code: Code QRA
Advisory panel: Neurology
Date received: 2023-03-24
Decision date: 2023-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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