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 Electrocardiograph
510(k) Number K081473
Device Name HERO, VERSION 2.0
Applicant
MEDICAL PREDICTIVE SCIENCE CORP.
2246 IVY RD., SUITE 17
CHARLOTTESVILLE,  VA  22903
Applicant Contact WILLIAM E KING
Correspondent
MEDICAL PREDICTIVE SCIENCE CORP.
2246 IVY RD., SUITE 17
CHARLOTTESVILLE,  VA  22903
Correspondent Contact WILLIAM E KING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/27/2008
Decision Date 06/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-