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 Interventional Fluoroscopic X-Ray System
510(k) Number K140138
Device Name HEARTNAVIGATOR RELEASE 2.0
Applicant
Philips Medical Systems Nederland B.V.
3959 Van Dyke Rd., Suite 245
Lutz,  FL  33558
Applicant Contact MICHAEL DAYTON
Correspondent
Philips Medical Systems Nederland B.V.
3959 Van Dyke Rd., Suite 245
Lutz,  FL  33558
Correspondent Contact MICHAEL DAYTON
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received01/22/2014
Decision Date 06/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-