FDA 510(k) Application Details - K082987

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K082987
Device Name Coil, Magnetic Resonance, Specialty
Applicant INVIVO
3545 S.W. 47TH AVE.
GAINESVILLE, FL 32608 US
Other 510(k) Applications for this Company
Contact ANDREW ADAMS
Other 510(k) Applications for this Contact
Regulation Number 892.1000

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

  More FDA Info for this Product Code
Date Received 10/07/2008
Decision Date 11/06/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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