FDA 510(k) Application Details - K002889

Device Classification Name Stimulator, Nerve, Peripheral, Electric

  More FDA Info for this Device
510(K) Number K002889
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact SHEILA HEMEON-HEYER
Other 510(k) Applications for this Contact
Regulation Number 868.2775

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

  More FDA Info for this Product Code
Date Received 09/15/2000
Decision Date 04/06/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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