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 Electrode, Depth
510(k) Number K140680
Device Name LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
Applicant
ALPINE BIOMED APS
TONSBAKKEN 16 - 18
SKOVLUNDE,  DK DK-2740
Applicant Contact Seamus O'Connor
Correspondent
ALPINE BIOMED APS
TONSBAKKEN 16 - 18
SKOVLUNDE,  DK DK-2740
Correspondent Contact PETER JORGENSEN
Regulation Number882.1330
Classification Product Code
GZL  
Date Received03/18/2014
Decision Date 12/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-