FDA 510(k)

Sleepio®

K-Number: K233577 · 2024-08-05

Decision Date2024-08-05

Product CodeQVO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Sleepio® is the device name listed in this FDA 510(k) record. The listed applicant is Big Health, Inc.. It received FDA 510(k) clearance on 2024-08-05 under 510(k) 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. The listed applicant is Big Health, Inc.. The 510(k) number is K233577.

When did Sleepio® receive FDA 510(k) clearance?

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

Who is the listed applicant for Sleepio®?

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

What is the FDA product code for Sleepio®?

The FDA product code for Sleepio® is QVO.

Other records listing Big Health, 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.

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Official Source

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