FDA 510(k) Application Details - K091553

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

  More FDA Info for this Device
510(K) Number K091553
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NINGBO DIAIER ELECTRONIC CO., LTD.
NO. 1 BEIXING ROAD
YAOXI INDUSTRIAL ZONE
YUYAO CITY, ZHEJIANG CN
Other 510(k) Applications for this Company
Contact LAO XIKUN
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 05/27/2009
Decision Date 09/21/2009
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