Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K031119
Device Name MAYO CLINIC BC-10 1.5T
Applicant
MAYO MEDICAL VENTURES
200 FIRST ST SW
ROCHESTER,  MN  55905
Applicant Contact JADE SADOSTY
Correspondent
MAYO MEDICAL VENTURES
200 FIRST ST SW
ROCHESTER,  MN  55905
Correspondent Contact JADE SADOSTY
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/08/2003
Decision Date 07/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-