FDA 510(k)

EndeavorRx

K-Number: K231337 · 2023-12-13

Decision Date2023-12-13

Product CodeQFT

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EndeavorRx is the device name listed in this FDA 510(k) record. The listed applicant is Akili Interactive Labs, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231337. The device is classified under product code QFT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndeavorRx?

EndeavorRx is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Akili Interactive Labs, Inc.. The 510(k) number is K231337.

When did EndeavorRx receive FDA 510(k) clearance?

EndeavorRx received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231337.

Who is the listed applicant for EndeavorRx?

The FDA 510(k) record lists Akili Interactive Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndeavorRx?

The FDA product code for EndeavorRx is QFT.

Other records listing Akili Interactive Labs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233496EndeavorOTC

Related Devices (Code: QFT)

K243729PrismiraLumos Labs, Inc.K233496EndeavorOTCAkili Interactive Labs, Inc.

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.