SPARK Scan— 510(k) K231457

Substantially Equivalent

Spark Neuro, Inc.

FDA 510(k) clearance K231457 for SPARK Scan, Substantially Equivalent on 2023-08-18. Applicant: Spark Neuro, Inc..

Clearance details

Applicant: Spark Neuro, Inc.
Product code: Code GWQ
Advisory panel: Neurology
Date received: 2023-05-19
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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