• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name neurological stereotaxic instrument
510(k) Number K042391
Device Name KOLIBRI IMAGE GUIDED SURGERY SYSTEM
Original Applicant
BRAINLAB AG
ammerthalstrasse 8
heimstetten,  DE 85551
Original Contact jens witte
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/02/2004
Decision Date 10/19/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-