510(k) K150154

Device: ANAM Test System: Military Battery
Applicant: Vista LifeSciences, Inc.
510(k) number: K150154
Product code: PKQ
Decision: Substantially Equivalent (SESE)
Decision date: 2015-08-28
Date received: 2015-01-23
Regulation: 882.1470
Classification name: Computerized Cognitive Assessment Aid
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Lori White
Address: P.O. Box 4670 Parker CO US 80134 80134

FDA Registration Numbers#

3008394853
3014389576
3008660657

Source Documents#

Other 510(k) Records For Product Code PKQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K161328	Cantab Mobile	Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.	2017-01-13
DEN130033	COGNIVUE	Cerebral Assessment Systems, Inc.	2015-06-05

Legacy Summary#

summary

FDA Review#

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