SPEAC System— 510(k) K182180

Substantially Equivalent

Brain Sentinel, Inc.

FDA 510(k) clearance K182180 for SPEAC System, Substantially Equivalent on 2019-05-11. Applicant: Brain Sentinel, Inc..

Clearance details

Applicant: Brain Sentinel, Inc.
Product code: Code POS
Advisory panel: Neurology
Date received: 2018-08-13
Decision date: 2019-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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