FDA 510(k) Application Details - K151246

Device Classification Name Blood Pressure Cuff

  More FDA Info for this Device
510(K) Number K151246
Device Name Blood Pressure Cuff
Applicant Jiaxing Zhongfa Medical Products Co., Ltd.
No.38 Building 1, Zhong Fa Group
ZhuangShi Village, FengQiao Town, Nanhu Dst
Jiaxing 314008 CN
Other 510(k) Applications for this Company
Contact Mao Xiaohua
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 05/11/2015
Decision Date 06/30/2015
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



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