FDA 510(k) Application Details - K132444

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K132444
Device Name Coil, Magnetic Resonance, Specialty
Applicant MONTERIS MEDICAL
1193 SHERMAN STREET
ALAMEDA, CA 94501 US
Other 510(k) Applications for this Company
Contact BRIAN J EDWARDS
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 08/06/2013
Decision Date 01/27/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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