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 Computer, Diagnostic, Programmable
510(k) Number K992703
Device Name CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
Applicant
PREMIER HEART, LLC.
601 13TH STREET, N.W.
SUITE 901 SOUTH
WASHINGTON,  DC  20005
Applicant Contact WILLIAM D HARE
Correspondent
PREMIER HEART, LLC.
601 13TH STREET, N.W.
SUITE 901 SOUTH
WASHINGTON,  DC  20005
Correspondent Contact WILLIAM D HARE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/12/1999
Decision Date 03/21/2000
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
-
-