The following data is part of a premarket notification filed by Vista Lifesciences, Inc. with the FDA for Anam Test System: Military Battery.
Device ID | K150154 |
510k Number | K150154 |
Device Name: | ANAM Test System: Military Battery |
Classification | Computerized Cognitive Assessment Aid |
Applicant | Vista LifeSciences, Inc. PO Box 4670 Parker, CO 80134 |
Contact | Lori White |
Correspondent | Calley Herzog Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
Product Code | PKQ |
CFR Regulation Number | 882.1470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-23 |
Decision Date | 2015-08-28 |
Summary: | summary |