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 neurological stereotaxic instrument
510(k) Number K051746
Device Name ELEKTA ESARTE FRAME SYSTEM
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
P.O.BOX 7593
STOCKHOLM,  SE S-103 93
Applicant Contact PETER LOWENDAHL
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
P.O.BOX 7593
STOCKHOLM,  SE S-103 93
Correspondent Contact PETER LOWENDAHL
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
LHN  
Date Received06/29/2005
Decision Date 07/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-