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510(k) K201376

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

K201376 is an FDA 510(k) premarket notification submitted by Vista Lifesciences, Inc. for the device "ANAM Test System". The FDA issued a decision of Substantially Equivalent on March 25, 2021. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471. Vista Lifesciences, Inc. has at least 1 other 510(k) clearance on record.

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)

Other clearances for product code POM

  • K241737 — Sway System Sports Plus (February 15, 2025)
  • K231688 — ImPACT Version 4 (September 16, 2023)
  • K202485 — ImPACT Version 4 (December 25, 2020)
  • K181223 — ImPACT (October 20, 2018)
  • K170551 — ImPACT Quick Test (June 21, 2017)
  • K170209 — ImPACT (February 23, 2017)
  • DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid (August 22, 2016)

FDA data resources