FDA 510(k) Application Details - K221913

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K221913
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Street Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Fang Meisong Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2022
Decision Date	10/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review