FDA 510(k) Application Details - DEN230041

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230041
Device Name	Sleep Apnea Feature
Applicant	Samsung Electronics Co., Ltd 129 Samsung-ro, Yeoungton-gu Suwon-si KR Other 510(k) Applications for this Company
Contact	Hon Pak Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2023
Decision Date	02/06/2024
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review