ANAM Test System: Military Battery
FDA 510(k) clearance K150154 · decided 2015-08-28
Clearance details
- K-number
- K150154
- Device name
- ANAM Test System: Military Battery
- Applicant
- Vista Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-23
- Decision date
- 2015-08-28
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- PKQ
- Device class
- 2
- Regulation number
- 882.1470
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Parker, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| Cantab Mobile (K161328) | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | 2017-01-13 |
| COGNIVUE (DEN130033) | Cerebral Assessment Systems, Inc. | 2015-06-05 |
Recalls involving this device
No recalls on record reference this clearance.