FDA 510(k) Application Details - K221857

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K221857
Device Name	Blood Pressure Cuff
Applicant	Zhejiang LuDe Technology Development Co., Ltd. NO. 298 Jichang North Road, Longwan District Wenzhou 325024 CN Other 510(k) Applications for this Company
Contact	Iris Du Other 510(k) Applications for this Contact
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2022
Decision Date	10/13/2022
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