SPEAC System— 510(k) K200276

Substantially Equivalent

Brain Sentinel, Inc.

FDA 510(k) clearance K200276 for SPEAC System, Substantially Equivalent on 2021-02-06. Applicant: Brain Sentinel, Inc..

Clearance details

Applicant: Brain Sentinel, Inc.
Product code: Code POS
Advisory panel: Neurology
Date received: 2020-02-04
Decision date: 2021-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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