FDA 510(k) Application Details - K021240

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

  More FDA Info for this Device
510(K) Number K021240
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant EIKON HEALTHCARE DEVICE CORP.
NO 58, FU-CHIUN ST.
HSIN-CHU CITY, TW
Other 510(k) Applications for this Company
Contact JEN KE-MIN
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 04/18/2002
Decision Date 11/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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