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 block, beam-shaping, radiation therapy
510(k) Number K001163
Device Name DMLC IV-ERGO
Applicant
3D LINE USA, INC.
2807 OLD COURT RD.
BALTIMORE,  MD  21208
Applicant Contact KAREN H RIGAMONTI
Correspondent
3D LINE USA, INC.
2807 OLD COURT RD.
BALTIMORE,  MD  21208
Correspondent Contact KAREN H RIGAMONTI
Regulation Number892.5710
Classification Product Code
IXI  
Subsequent Product Code
MUJ  
Date Received04/10/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-