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FDA 510(k)

Cantab Mobile

K-Number: K161328 · 2017-01-13

Decision Date2017-01-13
Product CodePKQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cantab Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K161328. The device is classified under product code PKQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cantab Mobile?

Cantab Mobile is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.. The 510(k) number is K161328.

When did Cantab Mobile receive FDA 510(k) clearance?

Cantab Mobile received FDA 510(k) clearance on 2017-01-13, under 510(k) number K161328.

Who is the listed applicant for Cantab Mobile?

The FDA 510(k) record lists Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cantab Mobile?

The FDA product code for Cantab Mobile is PKQ.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.