The following data is part of a premarket notification filed by Cambridge Cognition Ltd., Us Agent: Clementi Associates Ltd. with the FDA for Cantab Mobile.
| Device ID | K161328 |
| 510k Number | K161328 |
| Device Name: | Cantab Mobile |
| Classification | Computerized Cognitive Assessment Aid |
| Applicant | CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD. TUNBRIDGE COURT, TUNBRIDGE LANE Bottisham, GB Cb25 9tu |
| Contact | Nancy D. Clementi |
| Correspondent | Nancy D. Clementi CLEMENTI ASSOCIATES LTD 919 CONESTOGA RD, BUILDING 3, SUITE 312 Rosemont, PA 19010 |
| Product Code | PKQ |
| CFR Regulation Number | 882.1470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2017-01-13 |