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 K901883
Device Name STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
Applicant
STEREOTACTIC IMAGE SYSTEMS, INC.
1425 CIRCLE WAY
SALT LAKE CITY,  UT  84103
Applicant Contact PETER HEILBRUN
Correspondent
STEREOTACTIC IMAGE SYSTEMS, INC.
1425 CIRCLE WAY
SALT LAKE CITY,  UT  84103
Correspondent Contact PETER HEILBRUN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/26/1990
Decision Date 03/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-