FDA 510(k) Application Details - K010341

Device Classification Name Endoscope, Neurological

  More FDA Info for this Device
510(K) Number K010341
Device Name Endoscope, Neurological
Applicant MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA, CA 93117-5500 US
Other 510(k) Applications for this Company
Contact JANET MCAULEY
Other 510(k) Applications for this Contact
Regulation Number 882.1480

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

  More FDA Info for this Product Code
Date Received 02/05/2001
Decision Date 04/20/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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