• 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 K191422
Device Name Neural Navigator
Applicant
Soterix Medical, Inc.
237 W 35 ST, 1401
new york,  NY  10001
Applicant Contact abhishek datta
Correspondent
Soterix Medical, Inc.
237 W 35 ST, 1401
new york,  NY  10001
Correspondent Contact abhishek datta
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Codes
GWF   IKN   OBP  
Date Received05/29/2019
Decision Date 04/06/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-