FDA 510(k) Application Details - DEN210039

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210039
Device Name	SNOO Smart Sleeper
Applicant	Happiest Baby, Inc. 3115 S. La Cienega Blvd. Los Angeles, CA 90016 US Other 510(k) Applications for this Company
Contact	Harvey Karp Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2021
Decision Date	03/30/2023
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review