FDA 510(k) Application Details - K082851

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

  More FDA Info for this Device
510(K) Number K082851
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNOVATION DR.
RP-2122
WAUWATOSA, WI 53226 US
Other 510(k) Applications for this Company
Contact MATTHIAS BUERGER
Other 510(k) Applications for this Contact
Regulation Number 870.2900

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

  More FDA Info for this Product Code
Date Received 09/29/2008
Decision Date 11/19/2008
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