FDA 510(k) Application Details - K210139

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K210139
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Ying Dai 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	01/19/2021
Decision Date	10/01/2021
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