FDA 510(k) Application Details - K020661

Device Classification Name System,Network And Communication,Physiological Monitors

  More FDA Info for this Device
510(K) Number K020661
Device Name System,Network And Communication,Physiological Monitors
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
Other 510(k) Applications for this Company
Contact KAREN WEBB
Other 510(k) Applications for this Contact
Regulation Number 870.2300

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

  More FDA Info for this Product Code
Date Received 03/01/2002
Decision Date 05/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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