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 K203639
Device Name StealthStation Cranial Software v1.3.2
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Taylor Gold West
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Taylor Gold West
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/14/2020
Decision Date 01/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-