510(k) K233872

Device

Daylight

Applicant

Big Health, Inc.

510(k) number

K233872

Product code

SCP

Decision

Substantially Equivalent (SESE)

Decision date

2024-08-30

Date received

2023-12-07

Regulation

882.5801

Classification name

Computerized Behavioral Therapy Device For Anxiety Disorders

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N