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 Accelerator, Linear, Medical
510(k) Number K142420
Device Name Patient Positioning Devices
Applicant
Macromedics BV
Kouwe Hoek 18
Waddinxveen,  NL 2741
Applicant Contact C de Keijzer
Correspondent
Macromedics BV
Kouwe Hoek 18
Waddinxveen,  NL 2741
Correspondent Contact C de Keijzer
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received08/28/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-