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 K143420
Device Name SYMBIS Surgical System
Applicant
IMRIS, Inc.
5101 Shady Oak Rd
Minnetonka,  MN  55343
Applicant Contact Sanjay Shah
Correspondent
IMRIS, Inc.
5101 Shady Oak Rd
Minnetonka,  MN  55343
Correspondent Contact Sanjay Shah
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/28/2014
Decision Date 10/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-