FDA 510(k)

EndeavorOTC

K-Number: K233496 · 2024-06-14

Decision Date2024-06-14

Product CodeQFT

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EndeavorOTC 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 2024-06-14 under 510(k) number K233496. 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 EndeavorOTC?

EndeavorOTC is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Akili Interactive Labs, Inc.. The 510(k) number is K233496.

When did EndeavorOTC receive FDA 510(k) clearance?

EndeavorOTC received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233496.

Who is the listed applicant for EndeavorOTC?

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 EndeavorOTC?

The FDA product code for EndeavorOTC 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.

K231337EndeavorRx

Related Devices (Code: QFT)

K243729PrismiraLumos Labs, Inc.K231337EndeavorRxAkili Interactive Labs, Inc.

Official Source

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