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510(k) K233577

Sleepio® by Big Health, Inc. — Product Code QVO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 5, 2024
Date Received: November 7, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Behavioral Therapy Device For Insomnia
Device Class: Class II
Regulation Number: 882.5801
Review Panel: NE
Submission Type

The device is intended to provide cognitive behavioral therapy to treat insomnia.