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 System, Image Processing, Radiological
510(k) Number K062031
Device Name CHASE CARDIAC ANALYSIS SYSTEM
Applicant
Chase Medical, LP
1876 Firman Dr.
Richardson,  TX  75081
Applicant Contact DAVID M HERNON
Correspondent
Chase Medical, LP
1876 Firman Dr.
Richardson,  TX  75081
Correspondent Contact DAVID M HERNON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/18/2006
Decision Date 09/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-