FDA 510(k) Application Details - K982410

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

  More FDA Info for this Device
510(K) Number K982410
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant REHABILICARE, INC.
1811 OLD HIGHWAY 8
NEW BRIGHTON, MN 55112 US
Other 510(k) Applications for this Company
Contact EDWARD F VALDEZ
Other 510(k) Applications for this Contact
Regulation Number 882.5890

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

  More FDA Info for this Product Code
Date Received 07/13/1998
Decision Date 11/06/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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