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 K081257
Device Name CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST., SCIENCE PARK
REHOVOT,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST., SCIENCE PARK
REHOVOT,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/02/2008
Decision Date 05/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-