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 |