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 system, nuclear magnetic resonance imaging
510(k) Number K964306
Device Name MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/29/1996
Decision Date 01/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-