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FDA 510(k)

FullFocus

K-Number: K201005 · 2020-07-15

ApplicantPaige.Ai, Inc.
Decision Date2020-07-15
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

FullFocus is a medical device manufactured by Paige.Ai, Inc.. It received FDA 510(k) clearance on 2020-07-15 under approval number K201005. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FullFocus?

FullFocus is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Paige.Ai, Inc.. The 510(k) number is K201005.

When was FullFocus approved by the FDA?

FullFocus received FDA 510(k) clearance on 2020-07-15, under approval number K201005.

What company makes FullFocus?

FullFocus is manufactured by Paige.Ai, Inc..

What is the FDA product code for FullFocus?

The FDA product code for FullFocus is QKQ.

Other Devices by Paige.Ai, Inc.

K241273FullFocus

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Official Source

View on FDA Database →

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

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