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 K041477
Device Name PATHFINDER
Applicant
Armstrong Healthcare Limited
Knaves Beech Business Centre
Loudwater
High Wycombe,  GB HP10 9QR
Applicant Contact PATRICK A FINLAY
Correspondent
Armstrong Healthcare Limited
Knaves Beech Business Centre
Loudwater
High Wycombe,  GB HP10 9QR
Correspondent Contact PATRICK A FINLAY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/03/2004
Decision Date 12/09/2004
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
-
-