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 detector and alarm, arrhythmia
510(k) Number K143359
Device Name CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
Applicant
LifeWatch Technologies Ltd.
2 Pekeris St.
Rehovot,  IL 7670202
Applicant Contact Asher Kassel
Correspondent
Life Watch
10255 W Higgins Road, Suite 100
Chicago,  IL  60018
Correspondent Contact Stephen Slavens
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received11/24/2014
Decision Date 09/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-