FDA 510(k) Application Details - K052704

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K052704
Device Name Coil, Magnetic Resonance, Specialty
Applicant INVIVO CORP.
N27 W23676 PAUL ROAD
PEWAUKEE, WI 53072 US
Other 510(k) Applications for this Company
Contact THOMAS E TYNES
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 09/28/2005
Decision Date 11/03/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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