ANAM Test System
FDA 510(k) clearance K201376 · decided 2021-03-25
Clearance details
- K-number
- K201376
- Device name
- ANAM Test System
- Applicant
- Vista Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-26
- Decision date
- 2021-03-25
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- POM
- Device class
- 2
- Regulation number
- 882.1471
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.