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 Display, Cathode-Ray Tube, Medical
510(k) Number K161767
Device Name Philips IntelliVue GuardianSoftware
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  DE 71034
Applicant Contact Michael Asmalsky
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  DE 71034
Correspondent Contact Michael Asmalsky
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Codes
DQK   OUG  
Date Received06/27/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-