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 K113474
Device Name 1.5T GEM FLEX COIL
Applicant
NEOCOIL, LLC
N27 W23910A PAUL RD.
PEWAUKEE,  WI  53072
Applicant Contact STEVEN NICHOLS
Correspondent
NEOCOIL, LLC
N27 W23910A PAUL RD.
PEWAUKEE,  WI  53072
Correspondent Contact STEVEN NICHOLS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/22/2011
Decision Date 03/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-