FDA 510(k) Application Details - K022917

Device Classification Name Electrode, Cutaneous

  More FDA Info for this Device
510(K) Number K022917
Device Name Electrode, Cutaneous
Applicant HOME CARE TECHNOLOGY CO., LTD.
NO. 58, FU-CHIUN ST.
POSTAL CODE 300
HSIN-CHU CITY 300 TW
Other 510(k) Applications for this Company
Contact JEN KE-MIN
Other 510(k) Applications for this Contact
Regulation Number 882.1320

  More FDA Info for this Regulation Number
Classification Product Code GXY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/03/2002
Decision Date 03/04/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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