FDA 510(k) Application Details - K222420

Device Classification Name Blood Pressure Cuff

  More FDA Info for this Device
510(K) Number K222420
Device Name Blood Pressure Cuff
Applicant Wenzhou Xikang Medical Instruments Co., Ltd.
No. 1478 Haining Road, Haibin Street, Longwan District
Wenzhou 325024 CN
Other 510(k) Applications for this Company
Contact Wang Tiance
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 08/11/2022
Decision Date 11/21/2022
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

FDA Source Information for K222420


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact