FDA 510(k) Application Details - K212312

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K212312
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	LotusNine Medical Limited No. 2, Ln. 223, Sec. 1, Taiping Rd., Tsaotun Township Nantou County 524007 TW Other 510(k) Applications for this Company
Contact	Yating Chang 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	07/23/2021
Decision Date	01/27/2022
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