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 K030317
Device Name MODEL 1300GE-64: PEDIATRIC POSITIONER
Applicant
MIDWEST R.F. LLC.
535 NORTON DR.
HARTLAND,  WI  53029
Applicant Contact HELMUT KEIDL
Correspondent
MIDWEST R.F. LLC.
535 NORTON DR.
HARTLAND,  WI  53029
Correspondent Contact HELMUT KEIDL
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/30/2003
Decision Date 03/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-