FDA 510(k) Application Details - K240890

Device Classification Name	More FDA Info for this Device
510(K) Number	K240890
Device Name	PanopticAI Vital Signs
Applicant	PanopticAI Technologies Limited Room A, Ground Floor 3 Tin Hau Temple Road, North Point Hong Kong 0000 HK Other 510(k) Applications for this Company
Contact	Tsz Tai Chan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QME Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2024
Decision Date	12/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review