Cantab Mobile
FDA 510(k) clearance K161328 · decided 2017-01-13
Clearance details
- K-number
- K161328
- Device name
- Cantab Mobile
- Applicant
- Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-12
- Decision date
- 2017-01-13
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- PKQ
- Device class
- 2
- Regulation number
- 882.1470
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bottisham, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cambridge Cognition
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANAM Test System: Military Battery (K150154) | Vista Lifesciences, Inc. | 2015-08-28 |
| COGNIVUE (DEN130033) | Cerebral Assessment Systems, Inc. | 2015-06-05 |
Recalls involving this device
No recalls on record reference this clearance.