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FDA 510(k)

Sleepio®

K-Number: K233577 · 2024-08-05

ApplicantBig Health, Inc.
Decision Date2024-08-05
Product CodeQVO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sleepio® is a medical device manufactured by Big Health, Inc.. It received FDA 510(k) clearance on 2024-08-05 under approval number K233577. The device is classified under product code QVO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sleepio®?

Sleepio® is a medical device that received FDA 510(k) clearance on 2024-08-05. It is manufactured by Big Health, Inc.. The 510(k) number is K233577.

When was Sleepio® approved by the FDA?

Sleepio® received FDA 510(k) clearance on 2024-08-05, under approval number K233577.

What company makes Sleepio®?

Sleepio® is manufactured by Big Health, Inc..

What is the FDA product code for Sleepio®?

The FDA product code for Sleepio® is QVO.

Other Devices by Big Health, Inc.

K233872Daylight

Related Devices (Code: QVO)

K191716SomrystPear Therapeutics, Inc.

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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