meddevicedb.com FDA Device Reference

SNOO Smart Sleeper

DEN210039 Class II Direct
Decision Date
2023-03-30
Sponsor / Applicant
Happiest Baby, Inc.

Technical Specification

510(k) Submission ID DEN210039
Product Code QTG
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5690
Decision Date 2023-03-30
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

SNOO Smart Sleeper received FDA 510(k) clearance under submission number DEN210039, sponsored by Happiest Baby, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-03-30.

Classification & Regulation

This clearance is catalogued under FDA product code QTG and 21 CFR 880.5690, within the General Hospital review panel as a Class II device.