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 Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K011345
Device Name CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
Applicant
Reynolds Medical , Ltd.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Reynolds Medical , Ltd.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/02/2001
Decision Date 07/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-