FDA 510(k) Application Details - K024377

Device Classification Name

  More FDA Info for this Device
510(K) Number K024377
Device Name TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
Applicant KALACO SCIENTIFIC, INC.
131 GLENN WAY
SUITE 7
SAN CARLOS, CA 94070 US
Other 510(k) Applications for this Company
Contact GRACE BARTOO
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 12/31/2002
Decision Date 07/21/2003
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