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 K163666
Device Name neuro inspire
Applicant
Rensihaw Plc
New Mills
Wotton-Under-Edge,  GB GL12 8JR
Applicant Contact Roberto Liddi
Correspondent
Rensihaw Plc
New Mills
Wotton-Under-Edge,  GB GL12 8JR
Correspondent Contact Roberto Liddi
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/27/2016
Decision Date 09/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-