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 K033507
Device Name MRJ
Applicant
PARAMED SRL
719 CATALPA AVENUE
TEANECK,  NJ  07666
Applicant Contact DIANA UPTON
Correspondent
PARAMED SRL
719 CATALPA AVENUE
TEANECK,  NJ  07666
Correspondent Contact DIANA UPTON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/05/2003
Decision Date 01/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-