The following data is part of a premarket notification filed by Vista Lifesciences, Inc. with the FDA for Anam Test System.
Device ID | K201376 |
510k Number | K201376 |
Device Name: | ANAM Test System |
Classification | Computerized Cognitive Assessment Aid For Concussion |
Applicant | Vista LifeSciences, Inc. 7375 S. Peoria St. Suite 210 Englewood, CO 80112 |
Contact | Margaret E. Molloy |
Correspondent | Margaret E. Molloy Vista LifeSciences, Inc. 7375 S. Peoria St. Suite 210 Englewood, CO 80112 |
Product Code | POM |
CFR Regulation Number | 882.1471 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-26 |
Decision Date | 2021-03-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860334002121 | K201376 | 000 |