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510(k) K201376

ANAM Test System by Vista Lifesciences, Inc. — Product Code POM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2021
Date Received
May 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computerized Cognitive Assessment Aid For Concussion
Device Class
Class II
Regulation Number
882.1471
Review Panel
NE
Submission Type

For use as an assessment aid in the management of concussion.

Other clearances by Vista Lifesciences, Inc.

  • K150154 — ANAM Test System: Military Battery (August 28, 2015)

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