FDA 510(k) Application Details - DEN220091

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220091
Device Name	Dream Sock
Applicant	Owlet Baby Care, Inc. 3300 N. Ashton Blvd. Suite 300 Lehi, UT 84043 US Other 510(k) Applications for this Company
Contact	Jim Fidacaro Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2022
Decision Date	11/08/2023
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review