FDA 510(k) Application Details - K240929

Device Classification Name	More FDA Info for this Device
510(K) Number	K240929
Device Name	Sleep Apnea Notification Feature (SANF)
Applicant	Apple Inc. One Apple Park Way Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Lynda Ikejimba 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	04/04/2024
Decision Date	09/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review